Job Title: Validation Manager 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
To learn more about us, please visit our website: https://ocyonbio.com
