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.
- 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