Senior Process Validation Specialist – Southern California

Sep 5, 2018   //   by crosado   //   Job Opportunities  //  Comments Off on Senior Process Validation Specialist – Southern California

BioPharma Consulting JAD Group is in need of a Senior Process Validation Specialist for one of our clients in Southern California.

Position Summary
The Sr. Validation Specialist serves as the technical subject matter expert for Process Validation within QA and works closely with process development and translational sciences to transfer processes from clinical phases to commercial.  The primary responsibility is to validate processes used and to manufacture GMP clinical and commercial products in compliance with GMP regulations.   This position supports the tech transfer and process qualification efforts at our CMO partners to facilitate transfer to our Thousand Oaks cell therapy facility.

Responsibilities

  • Oversees development of process validation strategies, protocols and other documentation for Cell Therapy products as well as data analysis and compilation of data and results into summary and final reports.
  • Leads process validation related activities for the design, qualification and continued process verification of manufacturing processes, including identification of opportunities for improvement.
  • Reviews/assesses proposed changes to validated processes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.
  • Works with QA to investigate process issues and perform root cause analysis and implement solutions.
  • Supports Continuous Process Verification (CPV) through strong partnership with Process Science functions.
  • Maintains departmental expertise in process validation and related activities.  As a subject matter expert, represent these activities in discussions and communications with regulatory agencies (e.g., strategizing and preparation of regulatory submissions and in response to agency questions, as well as during facility inspections).
  • Interfaces with other departments (e.g., Engineering, Facilities, Manufacturing, Regulatory Affairs, Quality Control and Quality Assurance) to ensure achievement of objectives relating to process validation and associated activities; including compliance with all applicable standards.

Experience: Must have 5 -10 plus years of experience working on process validation, investigations, CAPA’s, CR, Commissioning and Qualification, Facilities, Utilities for Biotech Process

Location: Thousand Oaks, CA

Project Duration: 6 month plus

For further details or questions, please submit your inquiries and/or your updated resume to: info@bpc-jadgroup.com

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