Maintenance Specialist
Company:
OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased-appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with full regulatory systems capabilities and resources to enable CMC data supporting regulatory applications. Manufacturing and development spaces are designed to be autonomous while interconnected to systems required to support clinical and commercial requirements.
We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.
Place of Performance:
CII George Sanders, Aguadilla Pueblo, Aguadilla, P.R. 00603.
The Maintenance Specialist is responsible for maintenance and calibration program development, execution, and oversight within a cGMP manufacturing environment. This role supports both start-up and commercial operations by ensuring equipment reliability, regulatory compliance, and lifecycle management of facility systems, utilities, and infrastructure.
Maintenance & Calibration Program Development (Start-Up Phase)
· Develop, implement, and oversee the site’s maintenance and calibration systems, procedures, and CMMS configuration in alignment with cGMP and regulatory expectations.
· Build asset hierarchies, equipment criticality assessments, job plans, calibration standards, and preventive/predictive maintenance strategies.
· Support commissioning, qualification, FAT/SAT, engineering design reviews, and change control to ensure maintainability, reliability, and lifecycle compliance.
· Author and maintain maintenance-related SOPs, work instructions, calibration methods, and controlled forms.
· Establish initial spare parts strategies, stocking levels, and vendor service frameworks.
Maintenance Leadership (Commercial Operations Phase)
· Coordinate and direct preventive, predictive, and corrective maintenance and calibration activities.
· Lead, supervise, and develop maintenance and calibration personnel.
· Ensure maintenance teams are trained for aseptic interventions, cleanroom entry, gowning, and safety protocols.
· Collaborate with Production, Engineering, Supply Chain, and QA to align schedules with production priorities.
· Oversee maintenance of HVAC, environmental controls, critical utilities, and cleanroom infrastructure.
Reliability, Investigations & Continuous Improvement
· Own site maintenance metrics (uptime, OEE, MTBF, MTTR) and prepare KPI reports.
· Lead troubleshooting, root-cause analysis, and deviation investigations.
· Implement reliability improvements and predictive maintenance technologies.
· Lead cost-saving, safety-enhancing, and efficiency-focused improvement initiatives.
GMP Compliance & Quality Support
· Ensure all maintenance and calibration work adheres to cGMP, safety, environmental, and labor regulations.
· Maintain ALCOA+ data integrity for all maintenance and calibration records.
· Support internal/external audits and serve as SME for maintenance.
· Maintain qualified state of validated systems and support validation activities.
Systems, Budget & Administrative Responsibilities
· Serve as CMMS system owner.
· Develop and manage the maintenance budget.
· Manage procurement, spare parts, and external service providers.
· Manage attendance in ADP and participate in daily/weekly meetings.
· Bachelor’s degree in Mechanical, Electrical, Chemical Engineering, or related field.
· Minimum five (5) years of maintenance management experience in pharmaceutical, biologics, or medical device manufacturing.
· Experience with aseptic operations, critical utilities, and GMP requirements.
· Proven leadership and organizational skills with ability to drive reliability and continuous improvement.
· Strong analytical, problem-solving, and technical writing skills.
· Experience with maintenance best practices, reliability engineering, and OpEx tools (preferred).
· Proficient in MS Word, Excel, PowerPoint, and Project.
· Excellent communication and presentation skills.
· Maintenance program development and CMMS management.
· Reliability engineering and KPI management (OEE, MTBF, MTTR).
· Equipment lifecycle management and calibration systems.
· Root cause analysis and troubleshooting.
· Preventive, predictive, and corrective maintenance strategies.
• Combination of office and manufacturing environment work.
• Ability to sit, stand, and walk for extended periods.
• Ability to lift up to 25 pounds occasionally.
• Required use of appropriate PPE in laboratories, cleanrooms, and utility areas.
• May require occasional after-hours or weekend support depending on operational needs.
• Competitive salary (DOE.)
• Health, dental, and vision benefits
• Professional training and development opportunities
• Opportunities to participate in the company stock options program
We Are an Equal Opportunity Employer
OcyonBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you are looking to contribute to a growing organization advancing next-generation therapies while building your career in a dynamic and collaborative environment, OcyonBio offers the opportunity to make a meaningful impact. Join us as we continue shaping the future of healthcare.
To learn more about us, please visit our website: https://ocyonbio.com
Job Posting Title
Utilities Technician
Job Description
Company: OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements.
We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.
Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.
As a Utilities Technician at OcyonBio, you will be responsible for the operation, monitoring, and maintenance of facility and utility systems supporting cGMP manufacturing. This role reports to the Facility Utility Manager.
· Operate and maintain HVAC, chilled water, potable water, electrical, BMS, compressed air, and nitrogen systems.
· Perform preventive and corrective maintenance.
· Troubleshoot utility systems and implement repairs.
· Ensure compliance with FDA, EMA, and cGMP requirements.
· Document work using CMMS.
· Support validation and commissioning activities.
· Maintain logs and audit-ready documentation.
· Respond to alarms and emergency situations.
· Associate degree in technical field or equivalent experience.
· 2+ years in GMP-regulated environment.
· Experience with critical utilities.
· Knowledge of GMP utility systems.
· Understanding of cGMP documentation practices.
· Ability to read P&IDs and technical drawings.
· Hands-on mechanical and electrical troubleshooting.
· Familiarity with CMMS and BMS.
· Ability to work in a multi-skilled technician environment.
· Strong teamwork and communication skills.
· Valid Electrician or Refrigeration Technician License (Puerto Rico).
· Experience in industrial or GMP environments.
· Role requires work beyond licensed trade.
· Mechanical and electrical troubleshooting.
· Utility systems operation and maintenance.
· CMMS and BMS system usage.
· Interpretation of P&IDs and technical drawings.
· Documentation and compliance with cGMP practices.
· On-site role in Aguadilla, Puerto Rico.
· Work in manufacturing, laboratory, and utility environments.
· May require response to alarms and emergency situations.
We Are an Equal Opportunity Employer
OcyonBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you want to challenge yourself, accelerate your career, and give new hope to patients, there is no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
To learn more about us, please visit our website: https://ocyonbio.com
Read LessSenior EHS Specialist
Company:
OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased-appropriate development from early development through pre-clinical, clinical, and commercial stages. We operate as a cGMP incubator environment with full regulatory systems capabilities and resources to generate CMC data supporting global regulatory applications. Our manufacturing and development spaces are designed to function autonomously while remaining fully integrated with the systems required to support clinical and commercial operations.
We are committed to fostering a workplace free of explicit and implicit discrimination and harassment, where every individual feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.
Place of Performance:
CII George Sanders, Aguadilla Pueblo, Aguadilla, P.R. 00603.
The Senior EHS Specialist plays a key role in promoting a strong safety culture and ensuring compliance with environmental, health, and safety regulations within OcyonBio’s regulated biopharmaceutical manufacturing environment.
This role partners with Operations, Engineering, Facilities, and Quality teams to proactively identify risks, implement sustainable EHS programs, and support continuous improvement initiatives aligned with regulatory requirements and company standards.
• Support the development and implementation of EHS programs in compliance with cGMP, OSHA, EPA, and applicable regulatory requirements.
• Generate and maintain EHS documentation including policies, procedures, work permits, forms, and regulatory plans.
• Conduct routine safety inspections, risk assessments, and incident investigations.
• Assist in delivering EHS training to employees and contractors.
• Monitor hazardous waste management, chemical handling, and emergency preparedness programs.
• Collaborate with Operations, Engineering, and Facilities to address safety and environmental risks.
• Maintain accurate reporting and compliance records for EHS programs.
• Support and manage EHS-related regulatory inspections.
• Identify improvement opportunities and implement corrective and preventive actions.
• Bachelor’s degree in Environmental Science, Occupational Health, Safety Management, or related field required.
• Minimum 5 years of EHS experience in pharmaceutical, biotechnology, or regulated manufacturing environments preferred.
• Strong knowledge of OSHA, EPA, and FDA EHS requirements in manufacturing environments.
• Strong analytical and risk assessment capabilities.
• Ability to investigate incidents and implement corrective actions.
• Excellent organizational, communication, and teamwork skills.
• Ability to operate effectively in a fast-paced, startup environment.
• Combination of office, laboratory, and manufacturing environments.
• Ability to sit, stand, and walk for extended periods.
• Ability to lift up to 25 pounds occasionally.
• Required use of PPE including respirators, gloves, gowns, and safety glasses as needed.
• Exposure to regulated manufacturing environments and controlled laboratory conditions.
• Competitive salary (DOE.)
• Health, dental, and vision benefits
• Professional training and development opportunities
• Opportunities to participate in the company stock options program
We Are an Equal Opportunity Employer
OcyonBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you are looking to contribute to a growing organization advancing next-generation therapies while building your career in a dynamic and collaborative environment, OcyonBio offers the opportunity to make a meaningful impact. Join us as we continue shaping the future of healthcare.
To learn more about us, please visit our website: https://ocyonbio.com
Job Posting Title
Business Analyst – Digital Systems (MES/LIMS)
Job Description
Company: OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased-appropriate development from early development through pre-clinical, clinical, and commercial stages. We operate as a cGMP incubator environment with full regulatory systems capabilities and resources to generate CMC data supporting global regulatory applications. Our manufacturing and development spaces are designed to function autonomously while remaining fully integrated with the systems required to support clinical and commercial operations.
We are committed to fostering a workplace free of explicit and implicit discrimination and harassment, where every individual feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.
Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.
Job Overview:
OcyonBio is seeking a Business Analyst to serve as the internal subject matter expert (SME) to support and evolve our digital manufacturing ecosystem, including L7 ESP, MES, and LIMS systems.
This role bridges business operations and IT, ensuring that our systems are effectively implemented and configured, continuously improved, and aligned with manufacturing, quality, and regulatory needs. The ideal candidate will work closely with Manufacturing, Quality, IT and other to design, configure, and optimize workflows while ensuring compliance with regulatory standards.
This position is open to both hands-on with systems and capable of understanding business processes, with the potential to grow into a system owner and subject matter expert within the organization.
Responsibilities
· Become the internal SME for L7 ESP, MES, and LIMS platforms
· Translate business and manufacturing requirements into system workflows and configurations
· Design, configure, and optimize digital workflows within L7 and related systems
· Provide ongoing user support, troubleshooting, and system guidance across departments
· Facilitate system training sessions and develop user documentation
· Collaborate with IT, Quality, Manufacturing, and external vendors to implement system improvements
· Support system validation and ensure alignment with cGMP and FDA regulatory requirements
· Identify opportunities for process automation and operational efficiency
· Assist in change management and system adoption across the organization
Experience and Education
· Bachelor’s degree in Business, Information Systems, Engineering, Life Sciences, or a related field (or equivalent experience)
· Experience in business analysis, systems implementation, or process improvement is preferred but not required
· Exposure to MES, LIMS, ERP, or similar enterprise systems is a plus
· Experience in pharmaceutical, biotechnology, or regulated environments is highly desirable but not required
Qualifications
· Strong ability to understand and translate business processes into technical solutions
· Interest in becoming a system owner and long-term SME within the organization
· Understanding (or willingness to learn) of cGMP and FDA-regulated environments
· Ability to work cross-functionally with technical and non-technical teams
· Strong problem-solving and analytical thinking skills
· High attention to detail and structured approach to work.
Skills
· Business process analysis and workflow design
· Systems thinking and troubleshooting
· Clear communication and training facilitation
· Documentation and requirements gathering
· Adaptability in a fast-paced, startup environment
· Basic understanding of databases, data flows, or system integrations (preferred)
Working Conditions
· On-site role in Aguadilla, Puerto Rico
· Collaborative work environment involving office and manufacturing areas
· May require coordination with multiple departments and external vendors
What we offer:
· Competitive salary (DOE.)
· Health, dental, and vision benefits.
· Professional training and development opportunities.
· Opportunities to participate in the company stock options program
We Are an Equal Opportunity Employer
OcyonBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you are looking to contribute to a growing organization advancing next-generation therapies while building your career in a dynamic and collaborative environment, OcyonBio offers the opportunity to make a meaningful impact. Join us as we continue shaping the future of healthcare. To learn more about us, please visit our website: https://ocyonbio.com
Read LessHuman Resources Intern
Company:
OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased-appropriate development from early development through pre-clinical, clinical, and commercial stages. We operate as a cGMP incubator environment with full regulatory systems capabilities and resources to generate CMC data supporting global regulatory applications. Our manufacturing and development spaces are designed to function autonomously while remaining fully integrated with the systems required to support clinical and commercial operations.
We are committed to fostering a workplace free of explicit and implicit discrimination and harassment, where every individual feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.
Place of Performance:
CII George Sanders, Aguadilla Pueblo, Aguadilla, P.R. 00603.
The HR Coop – Training supports the Human Resources function by providing clerical and administrative assistance focused on employee training and development activities. This role is designed for a current student seeking practical exposure to HR processes, with primary responsibilities centered on coordination, documentation, and recordkeeping.
Essential Duties and Responsibilities
Maintain accurate training records, databases, and attendance logs.Support onboarding training documentation and track completion of required training.Prepare training materials, presentations, and attendance sheets.File, scan, and organize training-related documents (electronic and physical records).Monitor training completion status and follow up with employees as needed.Generate basic training reports and provide data support to the HR team.Provide general clerical and administrative support to the HR/Training function.Ensure confidentiality and proper handling of employee information at all times.• Office-based position with prolonged periods of sitting and computer use.
• Moderate office noise environment.
• Ability to operate standard office equipment including computers, printers, and phones.
• Occasional interaction with employees across departments.
We Are an Equal Opportunity Employer
OcyonBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you are looking to contribute to a growing organization advancing next-generation therapies while building your career in a dynamic and collaborative environment, OcyonBio offers the opportunity to make a meaningful impact. Join us as we continue shaping the future of healthcare.
To learn more about us, please visit our website: https://ocyonbio.com
Job Title: Senior Leader – Analytical (Tech) Lead
Job Description:
Company: OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements.
We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.
Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.
Job Overview:
We are seeking an accomplished Senior Leader – Analytical (Tech) Lead to provide strategic and operational leadership across analytical development, technology transfer, and commercial GMP testing for biologics and biosimilars. This role is critical to supporting global regulatory filings, commercial manufacturing, and lifecycle management programs.
The ideal candidate will bring deep expertise in analytical sciences, proven leadership within a reputed CDMO, and extensive experience interacting with global regulatory agencies.
Key Responsibilities:
Provide strategic leadership for Analytical Sciences across development, tech transfer, validation, and commercial testing activities for biologics, biosimilars, and peptides.Lead and oversee analytical method development, qualification, validation, and lifecycle management in a GMP environment.Drive technology transfer of analytical methods from development to commercial manufacturing sites, ensuring robustness and regulatory compliance.Ensure readiness and support for regulatory inspections and audits by US FDA, EMA, Health Canada, and other global agencies.Oversee commercial release and stability testing in compliance with global regulatory expectations.Provide technical oversight for advanced analytical techniques, including but not limited to:HPLC and related chromatographic methodsCell-based bioassays and potency assaysMicrobiology and sterility-related assaysLead biosimilar characterization programs, including analytical similarity assessments covering:Primary structure (e.g., amino acid sequence, post-translational modifications)Secondary structureTertiary and higher-order structureCollaborate cross-functionally with Process Development, Manufacturing, Quality, Regulatory Affairs, and external partners.Build, mentor, and lead high-performing global analytical teams across diverse cultures and time zones.Support global client interactions and act as a scientific and regulatory thought leader for analytical sciences.Required Qualifications & Experience:
Bachelor's or Master’s degree in Analytical Chemistry, Biochemistry, Biotechnology, Microbiology, or a related scientific discipline (PhD strongly preferred).Minimum 20 years of overall industry experience, with at least 5 years in a top-tier leadership role within a reputed CDMO or biopharmaceutical organization.Extensive hands-on and leadership experience in:Analytical Development and GMP commercial testingTech transfer for biologics and biosimilarsGlobal regulatory submissions and post-approval supportProven exposure to and successful management of US FDA, EMA, Health Canada, and other global regulatory inspections.Strong technical expertise in HPLC, cell-based assays, and microbiological assays.Demonstrated experience with biosimilar analytical characterization and similarity assessment is highly desirable.Deep understanding of ICH, FDA, EMA, and global regulatory guidelines relevant to analytical sciences.Excellent leadership, communication, and stakeholder management skills.Ability and willingness to relocate to Aguadilla, Puerto Rico, and work full-time on site.Proven ability to operate effectively across multicultural teams and multiple time zones.
What we offer:
Competitive salary (DOE.)Health, dental, and vision benefits.Professional training and development opportunities.Opportunities to participate in the company stock options programWe Are an Equal Opportunity Employer
OcyonBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you want to challenge yourself, accelerate your career, and give new hope to patients, there is no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
To learn more about us, please visit our website: https://ocyonbio.com
Job Title: Sterility Assurance Lead
Location: CII George Sanders Facility, Aguadilla Pueblo, Aguadilla, Puerto Rico 00603
About OcyonBio
OcyonBio is a biotechnology company based in Aguadilla, Puerto Rico, providing flexible cGMP manufacturing spaces and integrated quality and technical services to support the development, manufacture, and commercialization of biologics, gene therapies, and cell therapies.
Operating as a cGMP incubator, OcyonBio maintains robust quality systems, regulatory oversight, and technical expertise to generate CMC data suitable for global regulatory submissions. We are committed to compliance with FDA, EMA, and ICH requirements and to fostering a strong culture of quality, contamination control, and continuous improvement.
Job Overview
The Sterility Assurance Lead is accountable for ensuring that aseptic processing systems and sterility assurance controls are designed, implemented, monitored, and maintained in a validated state of control, in alignment with FDA Aseptic Processing Guidance, EU GMP Annex 1, and applicable ICH guidelines. This role owns the Contamination Control Strategy (CCS) and provides site-level technical leadership to ensure contamination risks are systematically identified, scientifically assessed, and effectively mitigated throughout the facility and product lifecycle. The Sterility Assurance Lead serves as the primary subject matter expert during regulatory inspections and drives inspection-ready, data-supported decision making.
Key Responsibilities
· Own, implement, and continuously improve the site Contamination Control Strategy (CCS), ensuring it is comprehensive, risk-based, and maintained throughout the lifecycle of facilities, utilities, equipment, processes, and products.
· Ensure aseptic processing controls are scientifically justified, data-driven, and demonstrably effective, maintaining a consistent state of control.
· Provide sterility assurance oversight for aseptic processing operations, including gowning qualification, aseptic behaviors, personnel training, and cleanroom practices.
· Collaborate cross-functionally with Operations, QC Microbiology, Engineering, and Validation to establish and maintain environmental monitoring, clean util-ity, cleaning, and sanitization programs, including justified alert/action limits and response strategies.
· Review, trend, and interpret microbiological and environmental monitoring data to identify adverse trends, emerging risks, and opportunities for risk reduction.
· Lead or provide expert input into microbiological investigations, contamination events, sterility failures, and environmental excursions, ensuring thorough root cause analysis and effective CAPAs.
· Ensure CAPAs are timely, sustainable, and verified for effectiveness, with documentation suitable for FDA and EMA inspection.
· Provide technical oversight for microbiological method transfers, validation, and verification, ensuring methods are fit for intended use.
· Act as the primary Sterility Assurance Subject Matter Expert during FDA, EMA, and other regulatory inspections and audits, presenting contamination control strategies, data trending, investigations, and risk assessments.
· Promote a strong contamination control culture through routine floor presence, coaching, training, and proactive quality engagement.
· Support continuous improvement initiatives and ensure sterility assurance considerations are embedded within change management and validation activities.
Education & Experience
· Bachelor’s degree in Microbiology, Biology, Chemistry, or a related scientific discipline (Master’s degree preferred).
· Minimum 5 years of experience in pharmaceutical or biopharmaceutical manufacturing within a GMP environment.
· Demonstrated experience supporting aseptic sterile manufacturing operations.
· Prior experience in microbiology, sterility assurance, or contamination control roles required.
· Strong working knowledge of FDA Aseptic Processing Guidance, EU GMP Annex 1 (2022), 21 CFR Parts 210/211, and ICH Q7, Q9, and Q10.
· Proven experience supporting FDA and/or EMA regulatory inspections.
Technical & Professional Competencies
· Ability to apply Quality Risk Management (ICH Q9) principles to sterility assurance and contamination control decisions.
· Strong analytical and data-trending skills with the ability to scientifically justify controls, mitigations, and conclusions.
· Experience leading complex investigations and driving effective, sustainable CA-PAs to closure.
· Strong communication and influencing skills, including direct interaction with regulators and auditors.
· Ability to balance regulatory compliance, product quality, and operational efficiency.
Working Conditions
· Work in classified cleanroom environments requiring aseptic gowning and strict contamination control practices.
· Travel may be required to support vendor qualification activities, FAT/SAT execution, and regulatory or client audits.
· Flexibility to support extended hours or weekend work during validation, inspections, or critical manufacturing activities.
Equal Opportunity Employer
Ocyonbio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without restate,to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. To learn more about us, please visit our website: https://ocyonbio.com
Read LessJob Title: Validation Manager
About Ocyonbio:
OcyonBio is a biotechnology CDMO based in Aguadilla, Puerto Rico, providing flexible cGMP facilities and integrated services to accelerate the development, manufacturing, and commercialization of biologics, cell & gene therapies, and advanced pharmaceutical products. Operating as a cGMP incubator-style environment, OcyonBio enables robust CMC data generation to support global regulatory submissions. We are committed to fostering an inclusive, respectful workplace where integrity, collaboration, and technical excellence are core to everything we do.
Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.
Job Overview:
OcyonBio is seeking a Validation Manager to establish, lead, and govern the site Validation Program, including full ownership of the Site Master Validation Plan (SMVP). This role is responsible for ensuring that facilities, utilities, and manufacturing equipment are initially qualified, periodically requalified, and maintained in a validated state throughout their lifecycle in a multi-client CDMO environment.
The Validation Manager provides both hands-on technical leadership and strategic oversight, leading teams of company employees and contract personnel, and serving as the validation subject matter expert during regulatory inspections and client audits.
The Validation Manager is also expected to actively and continuously leverage AI-enabled tools and digital technologies to improve validation planning, execution, documentation quality, trend analysis, and inspection readiness, while ensuring full compliance with cGMP and data integrity requirements.
Key Responsibilities:
Validation Program & Governance
Establish, lead, and maintain the sitewide Validation ProgramDevelop, approve, and govern the Site Master Validation Plan (SMVP)Ensure lifecycle validation control from design and commissioning through operation, requalification, and decommissioningCoordinate initial qualification, periodic requalification, and change-driven revalidation activitiesFacility & Utility Qualification
Lead validation and qualification of:Cleanrooms and HVAC systemsWFI, purified water, clean steam, and compressed gas systemsEnvironmental monitoring systemsImplement risk-based commissioning and qualification (C&Q) approaches in accordance with ASTM E2500 and ISPE guidelinesEnsure facility systems remain in a validated state and inspection-readyEquipment Startup & Qualification
Direct startup, commissioning, and qualification of critical manufacturing and laboratory equipment, including:Sterile filling lines, autoclaves, incubators, refrigerators, and freezersBioreactors, chromatography skids, and single-use systems (SUS)Solid dosage equipment (granulators, tablet presses, coating systems)Oversee FAT/SAT planning and executionApprove IQ/OQ/PQ protocols, reports, and traceability matricesTeam & Resource Leadership
Lead validation activities performed by company employees and contract validation personnelBuild, train, and manage validation resources to support project and operational needsOversee vendor qualification and validation service providersDigital Enablement & AI Utilization
Consistently use AI-enabled tools to enhance validation lifecycle activities, including protocol development, risk assessments, deviation analysis, trend identification, and continuous improvementApply AI tools to improve efficiency, consistency, and quality of validation documentation and data reviewEnsure responsible and compliant use of AI technologies in alignment with cGMP, data integrity (21 CFR Part 11), and company policiesIdentify and implement opportunities for AI and automation to strengthen validation processes while maintaining regulatory complianceCompliance & Inspection Readiness
Ensure compliance with FDA, EMA, MHRA, WHO, and ICH Q7–Q10 requirementsServe as Validation SME during regulatory inspections and client auditsLead deviation investigations, impact assessments, and CAPAs related to validation activitiesEnsure data integrity compliance, including 21 CFR Part 11Cross-Functional Collaboration
Partner with Engineering, Facilities, Quality, Manufacturing, and external vendors to ensure seamless project executionSupport technology transfers, facility expansions, and new client onboardingTrain operations and quality personnel on validation expectations, procedures, and digital toolsQualifications:
Education & Experience
Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline5+ years of progressive validation experience in pharmaceutical, biotech, or CDMO environmentsDemonstrated experience leading site-level validation programs and supporting regulatory inspectionsTechnical Expertise
Cleanroom and critical utility qualificationAseptic processing and sterilization validationEquipment commissioning and lifecycle validationRisk-based validation (ASTM E2500)Familiarity with automation systems (PLC/SCADA), ISPE Baseline Guides, and data integrity requirementsDemonstrated ability and willingness to continuously adopt and use AI-enabled tools in GxP-regulated environmentsLeadership & Soft Skills
Strong technical writing and documentation skillsExcellent problem-solving and decision-making abilitiesEffective communicator with strong cross-functional collaboration skillsAbility to lead in a fast-paced, multi-client CDMO environmentPreferred Qualifications
Lean Six Sigma, ASQ CQE, or ISPE certificationExperience with EU GMP Annex 1 (Sterility Assurance)Hands-on exposure to single-use bioprocessing and viral vector manufacturingExperience implementing or using AI tools within regulated GxP environmentsWorking Conditions
Work in classified cleanroom environments with aseptic gowningTravel may be required for FAT/SAT, vendor audits, and client engagementsFlexibility to support extended hours or weekends during critical validation phasesWhat we offer:
Competitive compensation and benefitsHealth, dental, and vision insuranceProfessional training and development opportunitiesEligibility for company stock option programsOpportunity to help build and shape a growing CDMOWe Are An Equal Opportunity Employer
Ocyonbio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
To learn more about us, please visit our website: https://ocyonbio.com
Job Description: Maintenance Technician
Company: OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued.
Place of Performance
CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.
Key Responsibilities
Maintenance & Calibration Execution
• Execute preventive, predictive, and corrective maintenance activities for manufacturing, laboratory, and utility equipment in a cGMP biologics manufacturing environment.
• Perform equipment calibrations according to approved procedures, schedules, and regulatory requirements.
• Document all maintenance and calibration activities accurately and contemporaneously in the CMMS, ensuring ALCOA+ data integrity.
• Support equipment commissioning, qualification, and validation activities, including FAT/SAT, IOQ, and PQ.
• Identify, troubleshoot, and resolve equipment issues and escalate complex problems as needed.
Procedure & Instruction Development (Start-Up Phase)
• Assist in the development, review, and revision of maintenance and calibration SOPs, work instructions, job plans, and controlled forms.
• Provide technical input to define preventive maintenance tasks, calibration methods, acceptance criteria, and frequencies.
• Support establishment of equipment asset hierarchies, criticality assessments, and maintenance strategies.
• Contribute to maintenance documentation supporting startup, tech transfer, and regulatory readiness.
Equipment, Utilities & Facilities Support
• Perform routine maintenance and troubleshooting of process equipment, cleanroom infrastructure, HVAC systems, and critical utilities.
• Support instrumentation, control systems, and electrical components; mechanical systems knowledge is a plus.
• Assist with spare parts identification, inventory management, and coordination with vendors and service providers.
• Ensure tools, test equipment, and calibration standards remain in a qualified state.
GMP Compliance & Quality Support
• Execute all work in compliance with cGMP, safety, environmental, and company requirements.
• Follow approved SOPs, work instructions, cleanroom gowning, aseptic practices, and safety procedures.
• Support deviation investigations, root cause analysis, CAPAs, and change control activities.
• Maintain qualified state of validated systems through proper execution and documentation.
Collaboration & Continuous Improvement
• Coordinate activities with the Maintenance Specialist, Engineering, Production, and QA.
• Support startup readiness activities including system walkdowns, equipment turnover, and punch list resolution.
• Participate in reliability, safety, and continuous improvement initiatives.
Qualifications
• Strong technical aptitude with hands-on experience in electrical, instrumentation, and/or mechanical maintenance.
• Working knowledge of preventive maintenance and calibration programs in regulated environments.
• Ability to read and interpret technical manuals, P&IDs, electrical schematics, and drawings.
• Strong attention to detail with effective documentation and communication skills.
Education & Experience
• Associate degree or technical certification in Industrial Maintenance, Electrical, Instrumentation, Mechanical Technology, or related discipline preferred.
• Minimum three (3) years of hands-on maintenance experience in pharmaceutical, biologics, biotechnology, or medical device manufacturing.
• Experience working in cGMP-regulated environments required.
• Knowledge of instrumentation, controls, and electricity preferred; mechanical knowledge is a plus.
What we offer:
• Competitive salary (DOE)
• Health, dental, and vision insurance
• Training and professional development
• Stock option program participation
Physical Requirements
• Ability to sit, stand, walk, bend, climb, and work in confined spaces as required.
• Able to lift up to 50 pounds occasionally.
• Ability to work in laboratories, cleanrooms, mechanical rooms, and manufacturing areas while wearing required PPE.
OcyonBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by law.
If you want to challenge yourself and accelerate your career, there is no better place than here with our team. Join us today.
To learn more about us, please visit our website: https://ocyonbio.com
Job Description: EHS Technician
Company: OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued.
Place of Performance
CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.
Key Responsibilities
EHS Program Execution & Waste Management
• Execute hazardous and non-hazardous waste management activities including segregation, labeling, storage, and disposal coordination.
• Support chemical management, spill response, and emergency preparedness activities.
• Perform routine EHS inspections and risk assessments.
EHS Documentation & Program Development (Start-Up Focus)
• Assist in development and maintenance of EHS SOPs, procedures, permits, forms, and logs.
• Support EHS documentation required for commissioning and qualification activities.
• Maintain accurate EHS records in compliance with regulatory requirements.
Commissioning & Qualification Support
• Support EHS execution during commissioning and qualification including hazard assessments and system walkdowns.
• Participate in JSAs and permit-to-work activities.
• Support contractor safety oversight.
GMP Compliance & Training Support
• Execute EHS activities in compliance with cGMP, OSHA, and EPA requirements.
• Assist with EHS training and onboarding activities.
• Support incident investigations and corrective actions.
Collaboration & Continuous Improvement
• Coordinate EHS activities with Operations, Engineering, Facilities, and Quality.
• Support audits and inspections.
• Participate in continuous improvement initiatives.
Qualifications
• Knowledge of OSHA and EPA requirements in manufacturing environments.
• Strong organizational and communication skills.
• Ability to identify hazards and follow safety procedures.
Education & Experience
• Associate or Bachelor’s degree in Environmental Science, Safety, or related field preferred.
• Two (2) to four (4) years of EHS experience in regulated manufacturing environments preferred.
• Experience with waste management and startup activities is a plus.
What we offer:
• Competitive salary (DOE)
• Health, dental, and vision insurance
• Training and professional development
• Stock option program participation
Physical Requirements
• Ability to sit, stand, walk, bend, and climb for extended periods.
• Ability to lift up to 25 pounds occasionally.
• Ability to work in manufacturing and laboratory environments while wearing PPE.
We Are an Equal Opportunity EmployerOcyonBio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by law.
If you want to challenge yourself and accelerate your career, there is no better place than here with our team. Join us today.
To learn more about us, please visit our website: https://ocyonbio.com
