Validation Manager

Ocyonbio•Aguadilla, PR

8d•Onsite

About The Position

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.

Requirements

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
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
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

Nice To Haves

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

Responsibilities

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
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
Direct startup, commissioning, and qualification of critical manufacturing and laboratory equipment, including: Sterile filling lines, autoclaves, incubators, and 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
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
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
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
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