Senior QA Validation Specialist

Senior Quality Validation Specialist

The Senior Quality Validation Specialist provides Quality Assurance oversight of validation activities across the site, with a focus on new equipment commissioning and qualification, equipment change controls, and equipment life cycle documentation. This role is responsible for ensuring that User Requirements Specifications (URS), risk assessments, qualification protocols, and cleaning validation activities are compliant with applicable regulatory expectations, industry guidance documents, and internal procedures. The Senior Quality Validation Specialist will have review and approval responsibilities for qualification protocols, execution, reports, and system life cycle documentation.

Essential Job Functions:

• Provide QA oversight and approval of equipment commissioning and qualification activities, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Review and approve equipment life cycle documents including User Requirements Specifications (URS), risk assessments (e.g., FMEA), acceptance (FAT/SAT) and qualification protocols, summary reports, and periodic reviews.
• Oversee equipment change controls from initiation through closure, ensuring appropriate qualification impact assessments are performed and documented.
• Provide QA oversight of cleaning validation activities, including review and approval of cleaning validation protocols, sampling plans, acceptance criteria, and summary reports.
• Hands-on design and execution of qualification protocols and associated testing for new and modified equipment and systems.
• Ensure all validation activities are performed in compliance with FDA, EMA, and applicable regulatory requirements, ICH guidelines, and internal SOPs.
• Participate in the development, review, and revision of validation-related SOPs, policies, and guidance documents.
• Serve as a QA subject matter expert during internal and external audits and regulatory inspections related to validation and qualification activities.
• Support deviation investigations and CAPA activities related to equipment qualification, cleaning validation, and system life cycle management.
• Collaborate cross-functionally with Engineering, Manufacturing, Technical Services, and other Quality groups to ensure validation activities are aligned with project timelines and regulatory expectations.
• Maintain current knowledge of regulatory trends, guidance documents, and industry best practices related to equipment qualification, cleaning validation, and system life cycle management.

Special Job Requirements:

• Bachelor's degree in a science or engineering field (e.g., Chemistry, Biology, Biochemistry, Chemical Engineering, Mechanical Engineering, or related discipline).
• Minimum of 5 years of experience in pharmaceutical, biopharmaceutical, or CDMO manufacturing with direct involvement in equipment qualification and validation activities.
• Demonstrated hands-on experience in designing and executing FAT/SAT, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Direct experience with cleaning validation programs, including protocol development, sampling strategies, analytical method considerations, and acceptance criteria establishment.
• Working knowledge of equipment and system life cycle management, including URS development, risk assessments, qualification, and periodic review.
• Thorough understanding of FDA, EMA, and ICH regulatory requirements and guidance documents applicable to equipment qualification and cleaning validation (e.g., FDA Process Validation Guidance, EU Annex 15, ISPE Commissioning and Qualification Baseline Guide).
• Familiarity with commissioning and qualification of utility systems (e.g., WFI, clean steam, compressed gases) and aseptic processing equipment (e.g., filling lines, lyophilizers, autoclaves, isolators).
• Experience with risk-based qualification approaches and ASTM E2500 methodology.
• Working knowledge of computerized system validation (CSV) and data integrity principles as they relate to equipment and systems.

Additional Preferences:

• Experience in a sterile injectable or aseptic manufacturing environment, particularly within a CDMO setting.
• Prior experience supporting regulatory inspections (FDA, EMA, Health Canada) or client audits related to validation activities.

Additional Info About INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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