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Validations Specialist

FISI - FUJIFILM Irvine Scientific Santa Ana Full-Time
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Overview

Irvine Scientific, a member of Fujifilm Holdings Corporation, is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in cell therapy and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large- scale production of biotherapeutics and vaccines. Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 45 years, Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. Additional information can be found at www.irvinesci.com.

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.

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External US

Responsibilities:

  • 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
  • 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

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.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

 

Recommended skills

Product Quality Assurance
Scheduling
Chemistry
Biology
Microbiology
Biochemistry
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Job ID: 2019-4403

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