Sr. Validation Engineer

2 weeks ago

Summit, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities:
  • Responsible for providing quality oversight for the qualification and validation activities for equipment, utilities, and facilities.
  • This role will be responsible for drafting, reviewing and approving qualification protocols/reports and any associated documentation in support of CQV activities for a new facility.
  • The Role also needs to drive the validation activity close out.
  • Assist in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, Turnover Packages, SOP's, specifications, traceability matrices, thermal mapping documents, and design documentation.
  • Provide expertise and solutions to issues regarding CQV Lifecycle documentation in regards for applicable FDA/EMEA Regulations
  • Support validation activities for project activities including review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and attendance at validation activities.
  • Provide support to enforce CQV guidelines, policies and procedures for equipment, analytical equipment, utilities, and facilities (Examples: Bioreactor, Incubator Chromatography Systems, harvest hold tank, washers, autoclaves, etc.)
  • Main focus of this role will be to Qualify Clean Rooms.
  • Employee will be required to work closely with Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.
  • Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.

Requirements:

  • Minimum of 9+years' experience in validation, biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
  • 1-3 years in a quality assurance or quality control role in an FDA-regulated company
  • Past experience with balance reports, hepa filter certs, and all associated utilities and equipment.
  • Strong knowledge of cGMP's 21CFR parts 2010 & 211, knowledge of 21CFR600 Biologics desirable.
  • Demonstrated knowledge of ISPE Baseline Guide 5, ASTM E-2500, EU regulatory requirements, and GAMP 5 Validation Lifecycle.
  • Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.
  • Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.

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