Validation Manager

Job DescriptionJob 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 & GovernanceEstablish, lead, and maintain the sitewide Validation ProgramDevelop, approve, and govern the Site Master Validation Plan (SMVP)Ensure lifecycle validation control from design and commissioning through operation, requalification, and decommissioningCoordinate initial qualification, periodic requalification, and change-driven revalidation activitiesFacility & Utility QualificationLead validation and qualification of:Cleanrooms and HVAC systemsWFI, purified water, clean steam, and compressed gas systemsEnvironmental monitoring systemsImplement risk-based commissioning and qualification (C&Q) approaches in accordance with ASTM E2500 and ISPE guidelinesEnsure facility systems remain in a validated state and inspection-readyEquipment Startup & QualificationDirect startup, commissioning, and qualification of critical manufacturing and laboratory equipment, including:Sterile filling lines, autoclaves, incubators, refrigerators, and freezersBioreactors, chromatography skids, and single-use systems (SUS)Solid dosage equipment (granulators, tablet presses, coating systems)Oversee FAT/SAT planning and executionApprove IQ/OQ/PQ protocols, reports, and traceability matricesTeam & Resource LeadershipLead validation activities performed by company employees and contract validation personnelBuild, train, and manage validation resources to support project and operational needsOversee vendor qualification and validation service providersDigital Enablement & AI UtilizationConsistently use AI-enabled tools to enhance validation lifecycle activities, including protocol development, risk assessments, deviation analysis, trend identification, and continuous improvementApply AI tools to improve efficiency, consistency, and quality of validation documentation and data reviewEnsure responsible and compliant use of AI technologies in alignment with cGMP, data integrity (21 CFR Part 11), and company policiesIdentify and implement opportunities for AI and automation to strengthen validation processes while maintaining regulatory complianceCompliance & Inspection ReadinessEnsure compliance with FDA, EMA, MHRA, WHO, and ICH Q7–Q10 requirementsServe as Validation SME during regulatory inspections and client auditsLead deviation investigations, impact assessments, and CAPAs related to validation activitiesEnsure data integrity compliance, including 21 CFR Part 11Cross-Functional CollaborationPartner with Engineering, Facilities, Quality, Manufacturing, and external vendors to ensure seamless project executionSupport technology transfers, facility expansions, and new client onboardingTrain operations and quality personnel on validation expectations, procedures, and digital tools

Qualifications: Education & ExperienceBachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline5+ years of progressive validation experience in pharmaceutical, biotech, or CDMO environmentsDemonstrated experience leading site-level validation programs and supporting regulatory inspections

Technical ExpertiseCleanroom and critical utility qualificationAseptic processing and sterilization validationEquipment commissioning and lifecycle validationRisk-based validation (ASTM E2500)Familiarity with automation systems (PLC/SCADA), ISPE Baseline Guides, and data integrity requirementsDemonstrated ability and willingness to continuously adopt and use AI-enabled tools in GxP-regulated environments

Leadership & Soft SkillsStrong technical writing and documentation skillsExcellent problem-solving and decision-making abilitiesEffective communicator with strong cross-functional collaboration skillsAbility to lead in a fast-paced, multi-client CDMO environment

Preferred QualificationsLean Six Sigma, ASQ CQE, or ISPE certificationExperience with EU GMP Annex 1 (Sterility Assurance)Hands-on exposure to single-use bioprocessing and viral vector manufacturingExperience implementing or using AI tools within regulated GxP environments

Working ConditionsWork in classified cleanroom environments with aseptic gowningTravel may be required for FAT/SAT, vendor audits, and client engagementsFlexibility to support extended hours or weekends during critical validation phasesWhat we offer: Competitive compensation and benefitsHealth, dental, and vision insuranceProfessional training and development opportunitiesEligibility for company stock option programsOpportunity 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