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Junior-Level Computer System Validation Engineer

PSC Biotech Corp. Novato, CA
  • Posted: over a month ago
  • Contractor
  • Benefits: Vision, Medical, Life Insurance, 401k, Dental

PSC Biotech is a leading pharmaceutical consulting firm for over 20 years with a global presence. We are currently seeking an Junior Level Computer System Validation Engineer in Novato, CA.

Resource will be working to complete the following goals:

  • Write Validation Protocols such as IQ, OQ and PQs
  • Execute Validation Protocols such as IQ, OQ and PQs to ensure compliance and adherence with applicable guidelines
  • Excel Spreadsheet Generation and Summary Report Writing for PQ studies
  • Review and modify Standard Operating Procedures (SOPs)
  • Generate test procedures to validate new or previously unvalidated processes
  • Write risks assessments and applicable test scripts according to GLP and 21 CFR Part 11 compliance guidelines and the Validation Master Plan.
  • Prepare validation summary reports for executed protocols.
  • Communicate Computer System Validation approaches and requirements during planning/audits.

Requirements:

  • Minimum Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, etc.), Computer Sciences, or Life Science major (Biochemistry, Chemistry, Pharmacy, etc.)
  • 6 months in Computer System Validation with strong pharmaceutical / biotech industry experience
  • Experience with 21 CFR Part 11 regulation/ EU regulations required.
  • Interested in making a contribution to the company while learning
  • Interested in learning validation and other activities required for companies to be compliant with Food and Drug Administration (FDA) regulations
  • Strong communication and interpersonal skills
  • No C2C
  • No Sponsorship

PSC Biotech Corp.

PSC Biotech Corporation is a global, employee owned, life sciences consultancy that performs projects and staff augmentation in the following disciplines: Engineering, Information Technology, Technical Services, Validation, Compliance, Regulatory Submissions, Clinical, Project Management and Quality Assurance. PSC Biotech, incorporated in 1996, has been performing projects globally for over 20 years.

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