Job Posting Title
Cleaning Operator Team 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:
The Cleaning Lead will play a critical role in the start-up and ongoing support of OcyonBio’s GMP cleanroom operations. This individual will be responsible for establishing, executing, and maintaining compliant cleaning and sanitation programs for new cleanroom facilities supporting parenteral manufacturing operations. The role requires a strong hands-on presence, deep understanding of cleanroom behaviors, and the ability to build and lead a high-performing cleaning team in a startup environment. We are looking for a motivated, detail-oriented professional with strong cleanroom experience who is comfortable working hands-on while helping to build systems and teams in a fast-paced startup environment.
Key responsibilities:
• Lead the start-up and implementation of GMP-compliant cleaning and sanitation programs for newly constructed cleanrooms.
• Establish routine and non-routine cleaning schedules, procedures, and workflows for classified manufacturing areas (e.g., ISO 5–8).
• Perform hands-on cleaning activities within cleanroom environments in accordance with cGMPs, SOPs, and aseptic practices.
• Support cleaning validation activities, including execution of protocols, sampling activities, and documentation.
• Author, review, and execute SOPs, logbooks, and cleaning records in compliance with Quality Systems.
• Recruit, train, and develop the cleanroom cleaning team, setting expectations for performance, compliance, and cleanroom behavior.
• Train personnel on gowning practices, aseptic techniques, contamination control, and proper use of cleaning agents and equipment.
• Ensure proper handling, preparation, and storage of approved cleaning and disinfecting agents.
• Collaborate cross-functionally with Quality, Facilities, Engineering, and Manufacturing to support operational readiness and inspection preparedness.
• Support deviation investigations, CAPAs, and continuous improvement initiatives related to cleaning and contamination control.
• Demonstrate flexibility and a “roll-up-the-sleeves” mindset to meet evolving operational needs typical of a startup organization.
Basic Qualifications:
• High school diploma or equivalent required; additional technical or life sciences education preferred.
• Minimum of 3 years of hands-on experience working in GMP cleanroom environments.
• Direct experience supporting cleaning and sanitation activities in classified areas.
• Strong understanding of cleanroom behaviors, gowning, and contamination control principles.
Preferred Qualifications:
• Experience in parenteral or aseptic manufacturing operations.
• Prior experience supporting cleanroom start-up or facility commissioning activities.
• Experience training and leading cleaning or facilities support personnel.
• Working knowledge of FDA cGMP regulations, aseptic processing guidelines, and industry best practices.
• Familiarity with cleaning validation concepts and environmental monitoring interfaces.
• Strong documentation skills and attention to detail.
• Ability to work independently, prioritize tasks, and adapt in a startup environment.
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
Read LessJob Posting Title: Packaging Supervisor
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: As a Packaging Supervisor at OcyonBio, you will provide direct oversight of packaging operations within a cGMP-regulated biopharmaceutical manufacturing environment. You will play a critical role in the installation, qualification, start-up, and routine operation of a fully automated packaging line while fostering a culture of compliance, safety, and continuous improvement.
Key responsibilities:
• Supervise day-to-day packaging operations, ensuring adherence to cGMPs, SOPs, batch records, and regulatory requirements.
• Lead and support the installation, commissioning, qualification (IQ/OQ/PQ), and validation activities for a fully automated packaging line.
• Provide hands-on technical leadership during equipment start-up, changeovers, routine operations, and troubleshooting of automated packaging systems.
• Execute and review packaging batch documentation, deviation reports, change controls, and CAPAs in accordance with quality systems.
• Collaborate cross-functionally with Engineering, Quality, Validation, and Supply Chain to support operational readiness and continuous improvement initiatives.
• Train, coach, and develop packaging operators, fostering accountability, technical proficiency, and a strong safety culture.
• Drive operational excellence through the identification and implementation of process improvements, efficiency gains, and risk mitigation strategies.
• Support regulatory inspections, internal audits, and readiness activities related to packaging operations.
• Operate effectively in a startup environment, demonstrating flexibility, initiative, and a “roll-up-your-sleeves” attitude to meet evolving business needs.
What we want from you
We are seeking a technically strong, highly motivated packaging professional who thrives in a startup setting and is comfortable balancing strategic oversight with hands-on execution.
Basic Qualifications:
• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline OR equivalent combination of education and experience.
• Minimum of 5 years of experience in biopharmaceutical or pharmaceutical packaging operations.
• Demonstrated experience working with automated packaging lines, including hands-on troubleshooting and operational support.
• Direct experience supporting equipment installation, commissioning, and qualification activities (IQ/OQ/PQ).
Preferred Qualifications:
• Prior supervisory or team-lead experience within a cGMP manufacturing environment.
• Strong working knowledge of FDA regulations, cGMPs, and global regulatory expectations related to packaging operations.
• Experience in startup or greenfield manufacturing environments.
• Proven ability to lead through ambiguity, prioritize effectively, and execute in fast-paced settings.
• Excellent documentation, communication, and cross-functional collaboration skills.
• Lean manufacturing or continuous improvement experience is a plus.
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
Read LessJob Posting Title: Warehouse Clerk
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:
The Warehouse Clerk supports daily warehouse operations by assisting with receiving, storing, and distributing materials. This role is key to keeping inventory organized and ensuring materials move efficiently and safely throughout the facility.
Key Responsibilities
Receive and inspect incoming materials and suppliesLabel and store materials in the correct warehouse locationsPick, prepare, and stage materials for internal use or outbound shipmentsHelp maintain accurate inventory records using forms or warehouse softwarePerform inventory counts and support cycle counting activitiesKeep the warehouse clean, safe, and well-organizedFollow all safety rules, company procedures, and standard operating instructionsWork closely with other departments such as Procurement, Manufacturing, and QualityQualifications
High school diploma or equivalentAt least 6–12 months of experience working in a warehouse, distribution, or inventory-related roleAbility to lift and move materials (up to ~50 lbs.)Comfortable using a computer or learning warehouse systemsBasic reading, writing, and math skillsStrong attention to detail and ability to follow instructionsPreferred Skills
Experience with inventory systems (ERP, WMS, or similar)Forklift or pallet jack experience (certification a plus)Bilingual (English/Spanish)Familiarity with safety and quality practices in a warehouse environmentWork Environment
Work is performed in warehouse and controlled environmentsMay require use of personal protective equipment (PPE)Standing, walking, and lifting required throughout the shift
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
Read LessJob description: QA 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 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.
Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.Role SummaryProvides strategic and technical leadership for the Pharmaceutical Quality System, ensuring robust quality oversight of facility start-up, technology transfer, analytical method transfer, manufacturing process transfer, and sustained commercial GMP operations.
Key ResponsibilitiesProvide strategic QA leadership aligned with ICH Q10 principlesLead high-impact quality risk assessments and CAPA programsOversee quality aspects of technology transfer and process lifecycle managementSupport regulatory inspections, submissions, and client auditsMentor QA staff and drive continuous improvement initiativesQualificationsBachelor’s degree required; advanced degree preferredAt least 5-8 years of QA experience in sterile biologics manufacturingDemonstrated leadership in quality systems and regulatory interactionsCore CompetenciesStrong quality mindset aligned with ICH Q10 Pharmaceutical Quality System principlesRisk-based decision making (ICH Q9) and lifecycle approach to qualityExcellent GMP documentation and data integrity practicesCross-functional collaboration in start-up and technology transfer environmentsContinuous improvement and inspection readiness focusWe 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: Senior Leader – Analytical Sciences
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.
Employment Type:
Full-Time
Job Overview:
We are seeking an accomplished Senior Leader – Analytical Sciences 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:
PhD 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: Pharmaceutical Facility Janitor
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.
Position Summary
We are seeking a reliable and detail-oriented Janitor / Cleaning Technician to join our pharmaceutical facility team. This role is responsible for cleaning and maintaining CNC (Controlled Not Classified) & NC (Non-Classified) corridors, bathrooms, and office areas. The position does not involve cleaning GMP production areas or classified laboratories, but requires adherence to pharmaceutical facility cleanliness, safety, and compliance standards.
Key Responsibilities
Perform daily and scheduled cleaning of CNC/NC corridors, bathrooms, and office spaces.Sweep, mop, vacuum, and disinfect assigned areas following facility SOPs.Replenish supplies such as hand soap, paper towels, and restroom products.Collect, segregate, and dispose of waste according to facility policies (general, recyclable, and regulated waste).Operate cleaning equipment (e.g., floor scrubbers, vacuums, mops) safely.Follow GMP awareness and contamination-control practices to prevent cross-contamination.Maintain cleaning logs, checklists, and documentation as required.Report any maintenance issues, safety hazards, or supply needs to the Facilities Supervisor.Comply with all facility safety regulations, PPE requirements, and OSHA standards.Qualifications
High school diploma or equivalent.Prior janitorial or facilities cleaning experience (pharma, healthcare, or regulated industry preferred).Ability to follow cleaning checklists, SOPs, and safety instructions.Basic understanding of sanitation practices, chemical handling, and workplace safety.Strong attention to detail and reliability.Good personal hygiene and professional appearance.Ability to work independently and as part of a team.Physical ability to lift up to 25 lbs, bend, stand, and walk for extended periods.Preferred (Not Required)
OSHA Safety Certification.Previous experience in pharmaceutical, biotech, healthcare, or hospital cleaning.What we offer:
Competitive salary (DOE)Health, dental & vision benefits.Professional training and development opportunities.Opportunities to participate in the company stock options program.Work Conditions / Physical Requirements
This position requires the ability to perform cleaning and sanitation tasks in office, bathroom, and corridor environments within a pharmaceutical facility. The role involves standing, walking, bending, and reaching for extended periods, as well as lifting and carrying items up to 25 lbs. Employees must be comfortable using cleaning equipment and handling cleaning chemicals in accordance with facility SOPs and safety standards. Proper use of personal protective equipment (PPE) is required at all times. Work is performed indoors in controlled areas, with strict adherence to OSHA and facility safety regulations.
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
