732-661-0400

Validation Specialist

  • Location: Irvine
  • Type: Direct Hire
  • Job #33251

Global Pharmaceutical Contract Manufacturer is seeking a Validation Specialist to join their Quality team!

Scope and Purpose of Position

Develops and implements solutions to validation issues.

Responsibilities

  1. Responsible for developing and recommending validation strategies and designing studies for the purpose of providing documented evidence that a system, equipment, method, or process has been validated.
  2. Conducts and processes qualifications programs, writes detailed protocols and reports to document the validation of systems/ equipment and provides validation support for facility and utility expansion, compliance upgrades, etc.
  3. Develops and implements solutions to validation issues.
  4. Operate validation equipment as need and execute protocol for validation.
  5. Prepare and manage multiple projects, including document/protocol preparation, testing, report generation, analytical method development and statistical data analysis.
  6. Lead the Validation / Sterilization group by providing training and guidance in completing the assignment.
  7. Review sterilization chart and release production sterilization cycle
  8. Work cross functionally to ensure department is delivering assignments on time.
  9. Makes recommendations and implements solutions.
  10. Support the Developing new products and processes that are competitive and meet all GMP and ISO requirements.
  11. Communicate with laboratory and QA personnel/ Engineering/ Operation/management to correct and improve deficiencies.
  12. Any and all other duties as assigned by immediate supervisor.

Required Knowledge, Skills and Abilities

  • Working knowledge of QA/QC principles
  • Strong understanding and knowledge in GMP/GLP/ISO guidelines.
  • Strong attention to detail
  • Excellent written/oral communication skills, computer knowledge (excel, word)
  • Able to facilitate in a cohesive manner
  • Eager to grow and learn
  • Ability to work independently with minimal supervision
  • Knowledge and experience of lab safety

Required Education and Experience

  • BS degree in Biochemistry, Chemistry, Engineering, Biology or closely related discipline required
  • 4+ year experience in Validation and Sterilization Science

INDWST1

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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