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Pharmaceutical Validation Manager Jobs (NOW HIRING)

Biosimilar Sciences PR LLC

PR · On-site

Validation Manager About Ocyonbio: OcyonBio is a biotechnology CDMO based in Aguadilla, Puerto Rico ... pharmaceutical products. Operating as a cGMP incubator-style environment, OcyonBio enables robust ...

Wellington Foods Inc

Validation Manager

Corona, CA · On-site

$95K - $105K/yr

The Validation Manager works with Quality, Manufacturing, Maintenance, Sanitation, and Regulatory ... At least 5 years of work experience in pharmaceutical, personal care, biotechnology, dietary ...

Wellington Foods Inc

Validation Manager

Corona, CA · On-site

The Validation Manager works with Quality, Manufacturing, Maintenance, Sanitation, and Regulatory ... At least 5 years of work experience in pharmaceutical, personal care, biotechnology, dietary ...

Phlow Corp.

Sr. Validation Manager

Petersburg, VA · On-site

Establish validation master plans (VMPs) and lifecycle validation programs. * Manage CQV budgets ... Bachelor's degree in Engineering, Pharmaceutical Sciences, or related technical field (Master ...

Phlow Corp

Sr. Validation Manager

Petersburg, VA

Establish validation master plans (VMPs) and lifecycle validation programs. * Manage CQV budgets ... Bachelor's degree in Engineering, Pharmaceutical Sciences, or related technical field (Master ...

Phlow Corp

Sr. Validation Manager

Petersburg, VA · On-site

Establish validation master plans (VMPs) and lifecycle validation programs. * Manage CQV budgets ... Bachelor's degree in Engineering, Pharmaceutical Sciences, or related technical field (Master ...

INCOG

Process Validation Manager

Fishers, IN · On-site

TSMS - Manager of Process Validation The Technical Services and Manufacturing Sciences (TSMS ... Minimum 5 years of pharmaceutical GMP experience required * 4+ years of experience in process ...

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Pharmaceutical Validation Manager information

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How much do pharmaceutical validation manager jobs pay per year?

As of Jun 9, 2026, the average yearly pay for pharmaceutical validation manager in the United States is $105,415.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $132,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Pharmaceutical Validation Manager, and why are they important?

To thrive as a Pharmaceutical Validation Manager, you need a solid background in pharmaceutical sciences, engineering, or a related field, often supported by a relevant degree and experience in GMP-regulated environments. Familiarity with validation lifecycle documentation, risk assessment tools, and regulatory software systems such as TrackWise or Veeva Vault is typically required. Strong leadership, problem-solving, and communication skills set outstanding managers apart, enabling them to lead cross-functional teams and ensure compliance. These skills and qualities are crucial for maintaining product quality, meeting regulatory standards, and ensuring the safe and efficient production of pharmaceuticals.

What does a Pharmaceutical Validation Manager do?

A Pharmaceutical Validation Manager oversees the validation processes for equipment, systems, and processes within pharmaceutical manufacturing to ensure compliance with regulatory standards such as FDA and EMA guidelines. Their responsibilities include planning, coordinating, and documenting validation activities, managing teams, and ensuring that products meet quality and safety requirements. They play a key role in ensuring that all manufacturing procedures consistently produce products that meet predetermined quality criteria. Additionally, they may liaise with regulatory agencies during inspections and audits.

What are some common challenges faced by Pharmaceutical Validation Managers during regulatory inspections?

Pharmaceutical Validation Managers often encounter challenges during regulatory inspections, such as ensuring all validation documentation is complete, up-to-date, and compliant with current Good Manufacturing Practices (cGMP). Another challenge is demonstrating that all equipment and processes consistently operate within specified parameters, especially when inspectors request traceability and data integrity. Being able to quickly and accurately address auditor questions, provide supporting evidence, and manage unexpected findings requires thorough preparation and strong organizational skills.
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Pharmaceutical Validation Manager jobs near you

Validation Manager

Biosimilar Sciences PR LLC

PR • On-site

Full-time

Medical, Dental, Vision

Posted 17 days ago

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: https://ocyonbio.com