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Senior Validation Engineer

2 months ago

Hopewell, New Jersey, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities:
  • Oversee quality assurance for the qualification and validation processes concerning equipment, utilities, and facilities.
  • Draft, review, and approve qualification protocols and reports, along with related documentation to support CQV initiatives for new facilities.
  • Drive the completion of validation activities.
  • Assist in the creation, review, and approval of cGMP documentation, including Master Validation Plans, FAT/SAT documents, Turnover Packages, SOPs, specifications, traceability matrices, thermal mapping documents, and design documentation.
  • Provide expert guidance and solutions for issues related to CQV Lifecycle documentation in compliance with FDA/EMEA regulations.
  • Support validation efforts for project activities, including the review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and participation in validation activities.
  • Enforce CQV guidelines, policies, and procedures for equipment, analytical instruments, utilities, and facilities (e.g., Bioreactor, Incubator, Chromatography Systems, harvest hold tank, washers, autoclaves).
  • Focus primarily on the qualification of clean rooms.
  • Collaborate closely with Manufacturing, Validation, Site Automation, Engineering, Quality Control, and Global Technical Operations (GTS) teams.
  • Ensure thorough investigation of validation discrepancies, errors, protocol failures, or testing errors, necessitating documented review and corrective actions for deviations.
Qualifications:
  • At least 5 years of experience in validation, biological quality assurance, and/or quality control within an FDA-regulated biotechnology or pharmaceutical environment, demonstrating progressive responsibility.
  • 1-3 years of experience in a quality assurance or quality control capacity in an FDA-regulated organization.
  • Previous experience with balance reports, HEPA filter certifications, and associated utilities and equipment.
  • Strong understanding of cGMP regulations, specifically 21CFR parts 2010 & 211, with knowledge of 21CFR600 - Biologics being advantageous.
  • Proven knowledge of ISPE Baseline Guide 5, ASTM E-2500, EU regulatory requirements, and GAMP 5 Validation Lifecycle.
  • Familiarity with risk assessments and the process of implementing well-documented, risk-based approaches.
  • Experience working with Manufacturing, Validation, Site Automation, Engineering, Quality Control, and Global Technical Operations (GTS) teams.