Senior Validation Specialist, GMP & CSV
Overview
Lead validation lifecycle activities for equipment, facilities, utilities, processes, and computerized systems in a GMP-regulated environment at Katalyst Healthcares & Life Sciences in Raleigh, NC. You will own qualification and validation deliverables including DQ, IQ, OQ, and PQ, ensuring compliance with FDA, EMA, and cGMP regulations. Collaborate with Engineering, Quality, Manufacturing, Automation, and Regulatory teams to drive validation excellence. This contract role offers the chance to mentor junior engineers and influence validation strategy across multiple systems.
What You'll Do10
- 1Lead validation lifecycle activities including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing systems.
- 2Author, review, and approve validation protocols, reports, risk assessments, and validation plans to ensure regulatory compliance.
- 3Execute equipment, process, cleaning, utility, facility, and computer system validation activities in a GMP environment.
- 4Support commissioning and qualification (C&Q) activities for new equipment and manufacturing systems, integrating with engineering and automation.
- 5Manage deviations, investigations, CAPAs, and change controls related to validation activities, ensuring timely resolution.
- 6Develop and maintain Validation Master Plans (VMPs) that align with regulatory expectations and company standards.
- 7Ensure compliance with cGMP, GxP, FDA, EU GMP, and data integrity requirements across all validation projects.
- 8Support regulatory inspections and internal/external audits by preparing documentation and serving as a subject matter expert.
- 9Collaborate with Engineering, Quality Assurance, Manufacturing, Automation, and Regulatory teams to streamline validation processes.
- 10Mentor junior validation engineers and specialists, providing technical guidance and fostering professional growth.
Requirements10
- 1Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, or a related field.
- 25+ years of validation experience in a GMP-regulated environment.
- 3Strong knowledge of IQ/OQ/PQ and process validation methodologies.
- 4Experience with equipment qualification and cleaning validation.
- 5Hands-on experience with Computer System Validation (CSV) including 21 CFR Part 11 and GAMP 5 guidelines.
- 6Proficiency in risk assessments, change control, and CAPA processes.
- 7Excellent technical writing and documentation skills for protocols and reports.
- 8Experience with FDA and EMA regulatory requirements for validation.
- 9Preferred: experience with MES, LIMS, SCADA, PLC, or ERP systems.
- 10Preferred: knowledge of Kneat, ValGenesis, TrackWise, or MasterControl validation tools.
Salary Insight
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