Validation Manager

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:

Full-time