Validation Manager

Biosimilar Sciences PR LLC

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

Lead and maintain the sitewide Validation Program, including the Site Master Validation Plan (SMVP).
Ensure lifecycle validation control (design/commissioning through operation, requalification/revalidation, and decommissioning).
Coordinate initial qualification, periodic requalification, and change-driven revalidation.
Lead qualification/validation of cleanrooms & HVAC; WFI/purified water/clean steam/compressed gases; and environmental monitoring systems.
Apply risk-based commissioning & qualification (C&Q) per ASTM E2500 and ISPE guidance.
Maintain facility systems in a validated, inspection-ready state.
Direct startup, commissioning, and qualification of critical manufacturing and lab equipment (e.g., sterile fill/finish, autoclaves, incubators, cold storage; bioreactors, chromatography skids, SUS; solid dosage equipment).
Oversee FAT/SAT planning and execution.
Approve IQ/OQ/PQ protocols, reports, and traceability matrices.
Lead validation work performed by internal staff and contractors.
Build, train, and manage validation resources to meet project and operational needs.
Oversee vendor qualification and validation service providers.
Use AI-enabled tools to improve protocol development, risk assessments, deviation analysis, trending, documentation quality, and continuous improvement.
Ensure compliant use of AI aligned with cGMP, data integrity, 21 CFR Part 11, and company policies.
Identify automation/AI opportunities that strengthen validation while maintaining regulatory compliance.
Ensure compliance with FDA/EMA/MHRA/WHO expectations and ICH Q7–Q10.
Serve as Validation SME during regulatory inspections and client audits.
Lead validation-related deviations, impact assessments, and CAPAs; ensure 21 CFR Part 11/data integrity compliance.
Partner with Engineering, Facilities, Quality, Manufacturing, and vendors to execute projects successfully.
Support tech transfers, facility expansions, and new client onboarding.
Train Operations and Quality staff on validation expectations, procedures, and digital tools.