Validations Specialist

Regulatory/Compliance | Santa Ana, CA

Job Function:

We are hiring for a Validations Specialist. The Validations Specialist performs necessary and appropriate process and equipment qualifications, studies and validations as a requirement for the manufacture of quality products. This includes validation of processes and equipment, process investigations, technical evaluation with regards to, but not limited to FDA/EU/CMDR compliance.

Job Duties:

  • Generating, implementing, documenting and approving of all installation, operation and performance qualifications, equipment and process validations, studies and cleaning validations
  • Training of personnel to perform validated procedures for equipment operation, product manufacture, and equipment cleaning
  • Approving documented procedures for hygiene and monitoring their implementation
  • Approving documented cleaning schedules and methods for relevant areas and equipment
  • Approving methods of microbiology with responsibility and authority to:
    • Assist QC in identifying contamination sources and recommending means of eradication
    • Assist QC in investigating pre-sterilization microbiological contamination
    • Approve sterilization validation documentation
  • Scheduling with various departments for execution of IOQ and PQ protocols
  • Developing Validation Master Plan Validations Listings, and customer requirements for the manufacture of quality products

Experience/Education:

  • BS/BA degree in Biology, Microbiology, or Chemistry
  • A minimum of 2 years’ experience performing equipment/process validations in a medical device, pharmaceutical, or food manufacturing industry
  • 2+ years in relevant laboratory experience, including experimental design
  • Manufacturing and QC experience beneficial
  • Knowledge of FDA guidelines on general principles of process validation and validation of cleaning processes, FDA, cGMP, QSR, and associated guidelines related to validations
  • Knowledge of microbiological and biochemical comprehension, technical proficiency

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Principals only. No recruiters please.

FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

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