LOCATION: Las Piedras / Gurabo / Juncos
We are seeking a Commissioning & Qualification Specialist to support a pharmaceutical manufacturing facilities in Juncos/Gurabo area. The specialist will be responsible for conducting commissioning and qualification activities of Class D facilities and equipment to ensure they comply with requirements and regulatory standards. This is a 9 month+ contract-based opportunity for an independent professional willing to work at client site.
Main Responsibilities:
Develop and execute qualification protocols (Commissioning, IQ, OQ, PQ) for pharmaceutical equipment and facilities. Ensure qualification and validation activities meet company procedures and regulatory requirements.Manage Change Controls by initiating or reviewing for approval prior to execution, tracking associated tasks to ensure timely completion, and documenting closure in full compliance with FDA regulations, cGMP requirements, and company quality system procedures.Perform installation and operational checks for pharmaceutical equipment and systems. Develop commissioning protocols and execute commissioning activities for Class D rooms. Identify and resolve technical issues during qualification activities.Create and maintain accurate and complete documentation, including protocols, test scripts, reports, and SOPs. Ensure traceability of all qualification and validation activities.Ensure compliance with global regulatory standards (e.g., FDA, ICH, etc.) and industry guidelines.Support the periodic review and requalification of pharmaceutical systems. Coordinate system upgrades, decommissioning, and troubleshooting.Partner with QC, validation, IT, and engineering teams to ensure seamless implementation.General Requirements:
Fluent in Spanish and English (spoken and written).Proficiency in Microsoft Office 365 (Teams, SharePoint, Outlook, Excel, Word, PowerPoint) and project management tools.Proficiency in documentation practices and attention to detail. Effective communication skills and ability to present complex technical information to diverse audiences.Excellent problem-solving skills and ability to work collaboratively in a cross-functional team environment.Excellent communication skills.Education Requirements:
Bachelor’s Degree in engineering, life sciences or other related fields.Experience Requirements:
3+ years C&Q experience in the Pharmaceutical Industry.In-depth knowledge of regulatory requirements (e.g., cGMP, FDA) related to commissioning, qualification, and validation activities.Strong understanding of equipment and facility qualification, risk assessments, and validation principles.Experience in conducting investigations, particularly related to deviations, and familiarity with Corrective and Preventive Action (CAPA) processes.Prior experience in the commissioning and qualification (C&Q) of Grade D cleanroom environments is highly preferred.Physical Requirements:
Ability to sit for long periods.Light physical activity may be required occasionally.Must be able to visit field locations as needed.Must be able to use personal protective equipment (PPE) when required.Ability to perform in a variety of industrial environments. Read LessLOCATION: On Site, Greenville, NC, USA
We are seeking a highly experienced Aseptic Process Validation Engineer / Specialist to support critical validation activities within a GMP-regulated pharmaceutical manufacturing environment. This is a full-time (40+ hour weekly) contract opportunity (3–6 months contract) for an independent contractor with proven experience in sterile and aseptic processing.
This role is focused on execution in the manufacturing environment, including media fills (APS), sterilization validation, environmental monitoring, and aseptic process validation activities. The ideal candidate brings deep technical expertise and is comfortable working directly on the floor to ensure processes consistently meet sterility and regulatory requirements.
This is not a documentation-only role — we are looking for someone who can actively support validation runs, troubleshoot in real time, and collaborate closely with Manufacturing, Quality, and Engineering teams.
Candidates with experience in Process Engineering or Cleaning Validation within pharmaceutical environments will also be considered.
Main Responsibilities:
Execute aseptic process validation activities, includingmedia fills (Aseptic Process Simulations – APS)Support development, review, and execution of validation protocols and reports.Collaborate with Manufacturing and Quality teams during aseptic operations and validation runs.Review and support interpretation of environmental monitoring (EM) data, as applicableto validation activities.Ensure compliance with cGMP and regulatory requirements for sterile manufacturing.Participate in risk assessments related to aseptic processing and contamination control strategies.Analyze validation data to confirm process controland compliance with sterile manufacturing requirements.Troubleshoot issues during validation execution, including aseptic failures and deviations.Support deviation investigations, root cause analysis, and CAPA implementation.Collaborate with Manufacturing, Quality Assurance,Regulatoryand Engineering teamstosupportprocess performance and resolve deviations.Other relevant activities.General Requirements:
Strong technical writing and documentation skills.Ability to work 100% on-site (hands-on executionrequired).Experience with aseptic processing and media fill execution (APS)Solid understanding of FDA, EMA, andcGMPrequirements.Experience working in regulated pharmaceutical manufacturing environments.Proficiencyin Microsoft Office 365.Abilityto work independently and manage multiple priorities.Education Requirements:
Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.Equivalentcombination of education and experience may be considered.Experience Requirements:
5+ years of experience in process validationwithin pharmaceutical or consumer health manufacturing.Experience in asepticprocess validation is a plus.Hands-on experience withmedia fills (APS), sterile manufacturingenvironmentsand validation protocol executionProven knowledge of cGMP, FDA, ICH, andotherregulatory requirements and guidance.Physical Requirements:
Ability to sit for extended periods of time.Ability to perform light physical activities as needed.Must be able to work in manufacturing and cleanroom environments. Ability to wear personal protective equipment (PPE) as required. Ability to perform in diverse industrial settings.We're hiring a part-time recruiter who is strong at proactive sourcing (not just posting jobs) and who can run an organized, candidate-friendly process from intake to start date.
You'll help us fill immediate openings for a current client and build a warm bench to support rapid growth into additional regulated manufacturers.
The Recruiter supports the identification, sourcing, screening, and coordination of qualified candidates for technical and professional roles within regulated industries such as pharmaceutical, biotechnology, and medical device manufacturing.
This role focuses on proactive talent sourcing, candidate relationship management, and coordination of the recruitment lifecycle from requisition intake to onboarding. The Recruiter works closely with LPMP leadership and client stakeholders to ensure staffing needs are met efficiently while maintaining a positive candidate experience and accurate documentation throughout the process.
The position requires strong organizational skills, attention to detail, and the ability to manage multiple open requisitions simultaneously in a fast-paced environment.
Main responsibilities:
Talent Sourcing & Candidate IdentificationActively source candidates through LinkedIn, Indeed, professional networks, referrals, and targeted outreach strategies.Develop and maintain pipelines of qualified candidates for recurring or anticipated roles.Conduct proactive outreach to passive candidates to build a warm bench for future staffing needs.Identify and engage candidates with experience in regulated industries such as pharmaceutical, biotech, or medical device manufacturing.Monitor sourcing channels and adjust strategies based on response rates and candidate availability.Recruitment Process ManagementCoordinate the full recruitment lifecycle including candidate screening, interview scheduling, feedback tracking, and offer coordination.Conduct initial candidate screenings to assess qualifications, experience, and alignment with role requirements.Coordinate interviews between candidates, LPMP staff, and client representatives.Maintain clear and consistent communication with candidates throughout the recruitment process.Ensure a professional and positive candidate experience from first contact through placement.Stakeholder CoordinationConduct intake meetings with internal stakeholders and clients to confirm role requirements, responsibilities, qualifications, compensation range, and hiring timelines.Serve as a point of contact between LPMP leadership, clients, and candidates during the recruitment process.Provide updates on recruitment progress, candidate pipelines, and hiring status.Support client communication when candidate submissions or interview coordination are required.Documentation & Recruitment TrackingMaintain accurate recruitment records in internal tracking systems, spreadsheets, or HR platforms such as ADP.Track candidate status throughout the recruitment lifecycle including sourcing, screening, interviews, and placement.Maintain recruitment dashboards and status reports for open positions.Ensure proper documentation and organization of candidate files, resumes, and supporting materials.Support onboarding preparation by confirming required documents and information prior to candidate start dates.Market Intelligence & Recruiting StrategyProvide feedback regarding market availability of talent, compensation trends, and sourcing effectiveness.Recommend adjustments to recruiting strategies based on candidate pipeline performance.Assist LPMP leadership in evaluating staffing feasibility for new projects or client opportunitiesIdentify opportunities to improve recruitment processes, sourcing strategies, and candidate engagement.General requirements:
Demonstrated strength in proactive sourcing and outreach (not only inbound applicants)Comfortable working in a fast-paced environment with shifting priorities, multiple requests, and frequent client touchpoints.Proficiency in Microsoft Office 365 (Excel, Word, PowerPoint)Experience with CANVA and ADP a plus.Availability to work on site and to adjust schedule, as needed.Strong organizational and time management skills.Excellent written and verbal communication skills.Strong interpersonal and stakeholder management skills.Education Requirements:
Bachelor’s degree in Human Resources, Business Administration, Communications, Psychology, or a related field is strongly preferred.A combination of education and relevant experience can be considered.Experience Requirements:
Minimum 3 years of experience in recruiting or talent sourcing, preferably within life sciences, technical professional services, pharmaceutical, biotech, or medical device industries, regulated manufacturing environments in Puerto Rico.Demonstrated experience recruiting technical roles such as engineers, project managers, compliance specialists, or similar positions is highly preferred.Preferred Requirements:
Fluent in Spanish and English (spoken and written).Experience supporting proposals/capture or staffing feasibility inputs for life sciences and federally funded work is preferred.Personal Attributes:
High sense of responsibility, reliability, and professional ethics.Strong analytical and problem-solving skills; ability to make sound decisions under time pressure.Ability to manage multiple projects simultaneously and prioritize effectively.High level of organization and attention to detail.Excellent interpersonal skills to work with multidisciplinary internal and external teamsRate: $15.00 per hour + performance add-ons
Read LessLOCATION: On Site, Houston TX, USA
We are seeking an experienced Project Manager with a strong background leading Capital & Construction Projects within the pharmaceutical or life sciences industry; this is a 5 years contract-based opportunity for an independent contractor with proven experience managing large-scale projects with budgets of up to $30 million USD. The ideal candidate will have expertise coordinating with manufacturing teams to plan and execute project activities without impacting production or regulatory compliance, along with demonstrated experience working in highly regulated environments, ensuring adherence to applicable regulations and Quality Management Systems (QMS). Additionally, the candidate should possess strong problem-solving skills, with the ability to propose practical and effective solutions to overcome operational and construction-related constraints and must be able to communicate and collaborate effectively with multidisciplinary teams—including engineering, maintenance, manufacturing, and quality—to ensure projects are executed safely, efficiently, on time, and within budget.
Main Responsibilities:
Lead and oversee capital and construction projects within pharmaceutical or life sciences environments, including facility expansions, renovations, and infrastructure upgrades, managing projects with budgets of up to $30 million USD.Coordinate with manufacturing, engineering, maintenance, and quality personnel to ensure proper execution of tasks.Coordinate and monitor projects through the entire project lifecycle.Develop, manage, and monitor project schedule and project budget.Ensure that all project activities are delivered on time, within scope, within budget, and in compliance with safety requirements.Identify risks and obstacles during execution and implement mitigation actions to minimize impacts.Perform risk management to minimize project risks.Ensure compliance with applicable regulatory and quality standards.Provide effective and timely communications with stakeholders and report progress to management.Promote best practices and continuous improvement in project management processes.General Requirements:
Bilingual (Spanish and English)Proficiency in Microsoft Office 365 (Project, Excel, Word, Power Point)PMP or LPP certifications highly preferredTravel Requirements:
Depending on the assigned project may be required to travel 0-10% of the time.Education Requirements:
Bachelor’s degree in Business, Engineering, Project Management, or related field or a combination of education and experience.Experience Requirements:
7+ year experience leading construction and facility improvement projects in the pharmaceutical or life sciences industry.Knowledge of regulatory requirements (FDA, cGMP) and Quality Management Systems (QMS).Experience coordinating with manufacturing teams to plan activities.Experience with budget development and monitoring preferred.Skills:
Strong problem-solving skills and ability to make decisions under pressure.Excellent verbal and written communication skills, capable of interacting with multidisciplinary teams.Ability to manage multiple projects simultaneously, meeting deadlines and budgets.Proactive, detail-oriented, and safety-focused. Read LessLOCATION: Las Piedras / Gurabo / Juncos
We are seeking a Commissioning & Qualification Specialist to support a pharmaceutical manufacturing facilities in Juncos/Gurabo area. The specialist will be responsible for conducting commissioning and qualification activities of Class D facilities and equipment to ensure they comply with requirements and regulatory standards. This is a 9 month+ contract-based opportunity for an independent professional willing to work at client site.
Main Responsibilities:
Develop and execute qualification protocols (Commissioning, IQ, OQ, PQ) for pharmaceutical equipment and facilities. Ensure qualification and validation activities meet company procedures and regulatory requirements.Manage Change Controls by initiating or reviewing for approval prior to execution, tracking associated tasks to ensure timely completion, and documenting closure in full compliance with FDA regulations, cGMP requirements, and company quality system procedures.Perform installation and operational checks for pharmaceutical equipment and systems. Develop commissioning protocols and execute commissioning activities for Class D rooms. Identify and resolve technical issues during qualification activities.Create and maintain accurate and complete documentation, including protocols, test scripts, reports, and SOPs. Ensure traceability of all qualification and validation activities.Ensure compliance with global regulatory standards (e.g., FDA, ICH, etc.) and industry guidelines.Support the periodic review and requalification of pharmaceutical systems. Coordinate system upgrades, decommissioning, and troubleshooting.Partner with QC, validation, IT, and engineering teams to ensure seamless implementation.General Requirements:
Fluent in Spanish and English (spoken and written).Proficiency in Microsoft Office 365 (Teams, SharePoint, Outlook, Excel, Word, PowerPoint) and project management tools.Proficiency in documentation practices and attention to detail. Effective communication skills and ability to present complex technical information to diverse audiences.Excellent problem-solving skills and ability to work collaboratively in a cross-functional team environment.Excellent communication skills.Education Requirements:
Bachelor’s Degree in engineering, life sciences or other related fields.Experience Requirements:
3+ years C&Q experience in the Pharmaceutical Industry.In-depth knowledge of regulatory requirements (e.g., cGMP, FDA) related to commissioning, qualification, and validation activities.Strong understanding of equipment and facility qualification, risk assessments, and validation principles.Experience in conducting investigations, particularly related to deviations, and familiarity with Corrective and Preventive Action (CAPA) processes.Prior experience in the commissioning and qualification (C&Q) of Grade D cleanroom environments is highly preferred.Physical Requirements:
Ability to sit for long periods.Light physical activity may be required occasionally.Must be able to visit field locations as needed.Must be able to use personal protective equipment (PPE) when required.Ability to perform in a variety of industrial environments. Read Less