Sr. Validation Engineer

Engineering | Santa Ana, CA

Job Description:

We are hiring a Sr. Validation Engineer. The Sr. Validation Engineer is responsible for performing necessary and appropriate process and equipment qualifications, studies, and validations as a requirement for the manufacture of quality products.

Responsibilities:

  • Develop and execute validation protocols associated with new products, equipment, systems, and processes used in the FISI facility.
  • Lead and support the execution of qualification/validation protocols (IQ/OQ/PQ/PV/CV/CSV), including the collection of samples, data, and completion of protocols.
  • Directly and indirectly complies and analyzes validation data, prepares reports, and makes recommendations for changes and/or improvements, as applicable.
  • Ensures that Validation management is notified of deviations from protocol criteria, supports the identification of root causes and resolutions.
  • Support the investigation of deviations and problem-solving activities to identify root cause(s).
  • Coordinates the scheduling of protocol execution and testing with affected departments and personnel. This includes, but is not limited to: Manufacturing, Quality Assurance/Control, R&D and Facilities.
  • Lead and support the generation and review of SOPs.
  • Train equipment operators or other staff on qualification/validation/study protocols and standard operating procedures, as required.
  • Support the execution of commissioning protocols such as Factory Acceptance Testing (FAT) / Site Acceptance Testing (SAT), as applicable.
  • Lead and support the development of project plans and timelines.
  • Lead and support the tracking of project goals and work within cross functional teams.
  • Provide guidance to the Validation Specialist(s) and oversee their activities, as requested.
  • May be required to perform other duties as assigned or as needed by Validation Manager.

Experience/Education:

  • S. in Bioengineering, Chemical Engineering or equivalent
  • A minimum of 6+ years performing equipment/process/facility qualifications/validations in a medical device, pharmaceutical, or food manufacturing industry.
  • 4+ years in a relevant validation role.
  • Process Engineering and Manufacturing Engineering experience beneficial.
  • Proficiency in Validation Specialist Level I and II functions.
  • Knowledge study design (e.g. DOE).
  • Advanced knowledge of process validation, cleaning validation, and computerized system validation.
  • Advanced knowledge of equipment/system/facility qualifications.
  • Knowledge of FDA/cGMP/QSR and associated guidelines relevant to validation.
  • Knowledge of microbiological and biochemical comprehension; technical proficiency.
  • Proficient oral and written communication proficiently

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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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