PR · On-site
Build, train, and manage validation resources to support project and operational needs * Oversee vendor qualification and validation service providers Digital Enablement & AI Utilization
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PR · On-site
Build, train, and manage validation resources to support project and operational needs * Oversee vendor qualification and validation service providers Digital Enablement & AI Utilization
Process Project Manager
Carolina, PR · On-site
... Validation, EHS, and external contractors. Key Responsibilities * Serve as the Owner ... Manage project scope, schedule, budget, risks, and change orders. * Develop project execution plans ...
Process Project Manager
Carolina, PR · On-site
... Validation, EHS, and external contractors. Key Responsibilities * Serve as the Owner ... Manage project scope, schedule, budget, risks, and change orders. * Develop project execution plans ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Manage project schedules, budgets, risks, and execution activities * Coordinate contractors and ... Collaborate with Engineering, Manufacturing, Facilities, Quality, and Validation teams * Ensure ...
Manage project schedules, budgets, risks, and execution activities * Coordinate contractors and ... Collaborate with Engineering, Manufacturing, Facilities, Quality, and Validation teams * Ensure ...
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
PR · On-site
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Construction Project Manager
Ponce, PR · On-site
$70K - $80K/yr
Construction Project Manager Department: Construction Employment Type: Full Time Location: Ponce ... Valid driver's license with a clean driving record. * Minimum of 21 years of age with at least 3 ...
Construction Project Manager
Ponce, PR · On-site
$70K - $80K/yr
Construction Project Manager Department: Construction Employment Type: Full Time Location: Ponce ... Valid driver's license with a clean driving record. * Minimum of 21 years of age with at least 3 ...
Set and manage project budgets, ensuring profitability and efficiency. * Documentation and ... Valid driver's license with a clean driving record. * Minimum of 21 years of age with at least 3 ...
Set and manage project budgets, ensuring profitability and efficiency. * Documentation and ... Valid driver's license with a clean driving record. * Minimum of 21 years of age with at least 3 ...
PR · On-site
Coordinating engineering, manufacturing, maintenance, validation, quality, and automation teams. * Managing project schedules, budgets, action items, risks, and project documentation. * Supporting ...
PR · On-site
$40 - $50/hr
Candidates with only support, validation, or coordination experience will not be considered ... Project Management Discipline: Own the project schedule using MS Project or equivalent tools.
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PR · On-site
$40 - $50/hr
Candidates with only support, validation, or coordination experience will not be considered ... Project Management Discipline: Own the project schedule using MS Project or equivalent tools.
PR · On-site
Management of the bidding process * Project Schedules (Primavera, MS Project, etc.) * Project ... Commissioning, Validation, & Start-up Support The Personality Part: * If you value healthy ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Quick apply
Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards ...
Validation Project Manager information
How does a validation project manager typically collaborate with cross-functional teams during a project?
A Validation Project Manager regularly collaborates with cross-functional teams such as quality assurance, regulatory affairs, engineering, and production to ensure that all validation activities meet regulatory standards and project timelines. This collaboration often involves coordinating meetings, aligning on project milestones, and facilitating clear communication to address any technical or compliance issues. Building strong working relationships across departments is crucial for anticipating challenges and ensuring a smooth validation process. Effective coordination helps to minimize delays and ensures that all documentation and testing requirements are thoroughly met.
What are the key skills and qualifications needed to thrive as a validation project manager, and why are they important?
To thrive as a Validation Project Manager, you need expertise in regulatory compliance, project management, and validation protocols, often supported by a degree in engineering, life sciences, or a related field. Familiarity with validation software, quality management systems (QMS), and certifications like PMP or Six Sigma are commonly required. Exceptional organizational, leadership, and communication skills help coordinate cross-functional teams and manage complex timelines. These skills are crucial to ensure validated processes comply with industry standards, mitigate risks, and deliver successful project outcomes.
What is a validation project manager?
A Validation Project Manager is a professional responsible for overseeing and coordinating validation activities in industries such as pharmaceuticals, biotechnology, or manufacturing. Their main duties include ensuring that systems, equipment, and processes meet regulatory standards and operate as intended. They manage project timelines, resources, and communication among cross-functional teams to ensure successful validation outcomes. Additionally, they maintain documentation and ensure compliance with industry regulations such as FDA or GMP. This role is crucial for maintaining product quality, safety, and regulatory compliance.
What is the difference between Validation Project Manager vs Quality Assurance Specialist?
| Aspect | Validation Project Manager | Quality Assurance Specialist |
|---|---|---|
| Certifications | GMP, ISO, PMP | ISO, Six Sigma, GMP |
| Work Environment | Regulated industries like pharma, biotech | Manufacturing, software, healthcare |
| Primary Focus | Ensuring validation processes and protocols | Maintaining quality standards and procedures |
| Employer Usage | Pharmaceutical, biotech, medical device companies | Manufacturers, software firms, healthcare providers |
The Validation Project Manager primarily oversees validation activities, ensuring compliance with industry standards, while the Quality Assurance Specialist focuses on maintaining overall quality standards across processes. Both roles require similar certifications and are common in regulated industries, but their core responsibilities differ in scope and focus.
What are popular job titles related to Validation Project Manager jobs in Puerto Rico?
For Validation Project Manager jobs in Puerto Rico, the most frequently searched job titles are:
What job categories do people searching Validation Project Manager jobs in Puerto Rico look for?
The top searched job categories for Validation Project Manager jobs in Puerto Rico are:
What cities in Puerto Rico are hiring for Validation Project Manager jobs?
Cities in Puerto Rico with the most Validation Project Manager job openings:
Full-time
Medical, Dental, Vision
Re-posted 26 days ago
Job description
Job 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 Program
- Develop, approve, and govern the Site Master Validation Plan (SMVP)
- Ensure lifecycle validation control from design and commissioning through operation, requalification, and decommissioning
- Coordinate initial qualification, periodic requalification, and change-driven revalidation activities
Facility & Utility Qualification
- Lead validation and qualification of:
- Cleanrooms and HVAC systems
- WFI, purified water, clean steam, and compressed gas systems
- Environmental monitoring systems
- Implement risk-based commissioning and qualification (C&Q) approaches in accordance with ASTM E2500 and ISPE guidelines
- Ensure facility systems remain in a validated state and inspection-ready
Equipment Startup & Qualification
- Direct startup, commissioning, and qualification of critical manufacturing and laboratory equipment, including:
- Sterile filling lines, autoclaves, incubators, refrigerators, and freezers
- Bioreactors, chromatography skids, and single-use systems (SUS)
- Solid dosage equipment (granulators, tablet presses, coating systems)
- Oversee FAT/SAT planning and execution
- Approve IQ/OQ/PQ protocols, reports, and traceability matrices
Team & Resource Leadership
- Lead validation activities performed by company employees and contract validation personnel
- Build, train, and manage validation resources to support project and operational needs
- Oversee vendor qualification and validation service providers
Digital Enablement & AI Utilization
- Consistently use AI-enabled tools to enhance validation lifecycle activities, including protocol development, risk assessments, deviation analysis, trend identification, and continuous improvement
- Apply AI tools to improve efficiency, consistency, and quality of validation documentation and data review
- Ensure responsible and compliant use of AI technologies in alignment with cGMP, data integrity (21 CFR Part 11), and company policies
- Identify and implement opportunities for AI and automation to strengthen validation processes while maintaining regulatory compliance
Compliance & Inspection Readiness
- Ensure compliance with FDA, EMA, MHRA, WHO, and ICH Q7–Q10 requirements
- Serve as Validation SME during regulatory inspections and client audits
- Lead deviation investigations, impact assessments, and CAPAs related to validation activities
- Ensure data integrity compliance, including 21 CFR Part 11
Cross-Functional Collaboration
- Partner with Engineering, Facilities, Quality, Manufacturing, and external vendors to ensure seamless project execution
- Support technology transfers, facility expansions, and new client onboarding
- Train operations and quality personnel on validation expectations, procedures, and digital tools
Qualifications:
Education & Experience
- Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline
- 5+ years of progressive validation experience in pharmaceutical, biotech, or CDMO environments
- Demonstrated experience leading site-level validation programs and supporting regulatory inspections
Technical Expertise
- Cleanroom and critical utility qualification
- Aseptic processing and sterilization validation
- Equipment commissioning and lifecycle validation
- Risk-based validation (ASTM E2500)
- Familiarity with automation systems (PLC/SCADA), ISPE Baseline Guides, and data integrity requirements
- Demonstrated ability and willingness to continuously adopt and use AI-enabled tools in GxP-regulated environments
Leadership & Soft Skills
- Strong technical writing and documentation skills
- Excellent problem-solving and decision-making abilities
- Effective communicator with strong cross-functional collaboration skills
- Ability to lead in a fast-paced, multi-client CDMO environment
Preferred Qualifications
- Lean Six Sigma, ASQ CQE, or ISPE certification
- Experience with EU GMP Annex 1 (Sterility Assurance)
- Hands-on exposure to single-use bioprocessing and viral vector manufacturing
- Experience implementing or using AI tools within regulated GxP environments
Working Conditions
- Work in classified cleanroom environments with aseptic gowning
- Travel may be required for FAT/SAT, vendor audits, and client engagements
- Flexibility to support extended hours or weekends during critical validation phases
What we offer:
- Competitive compensation and benefits
- Health, dental, and vision insurance
- Professional training and development opportunities
- Eligibility for company stock option programs
- Opportunity to help build and shape a growing CDMO
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.
To learn more about us, please visit our website: https://ocyonbio.com