Location: South San Francisco, California, United States
Sectors: Quality Assurance (QA)
Job Type: Contract
Validation Engineer - South SF- 1 Year Contract
- Periodic Reviews of validated equipment in SSFP, which entails review of change records for validation impact, through the TrackWise system.
- The Periodic Review will also include review of monitoring data trends and validation lifecycle documents. These reviews will be compiled in a Periodic Review summary report.
- Support revalidation execution on equipment to ensure the equipment has been operating in a validated state, Cleaning Validation activities, New Product Introduction (NPI), and qualification of changes to GMP equipment.
- Activities may include but are not limited to protocol generation, execution of protocols, swab and rinse water sampling, data analysis, reviewing worksheets, obtaining batch records and QC results, and summary report authoring.
- Work effectively with customers (System Owner and Technical SME and Quality) to complete these validation activities.
- Follow all safe work practices including use of appropriate Personal Protective Equipment and ensure training is up to date.
The Ideal Candidate:
- Experience in a GMP regulated environment, including GDP, and use quality systems and processes such as change control and discrepancy / deviation processes is desirable, but not required.
- B.S. in Chemical, Biochemical or Mechanical Engineering or Science discipline with 0-3 years of relevant experience
Sthree US is acting as an Employment Business in relation to this vacancy.