Senior validation engineer
Location
Santa Clara, CA | United States
Job description
The Sr. Validation Engineer needs to be an expert with lab equipment like Agilent HPLCs, GCs, centrifuges, and Analytical Balances among other types of instruments. The consultant will perform an initial assessment of the lab equipment and then report findings to leadership to help strategize the project since additional Validation Engineer support will likely be needed in 2024.
Top Requirements :
- BS degree minimum
- 7+ years of experience as a Validation Engineer working with Medical Device and Pharmaceutical companies
- Strong knowledge of FDA standards and regulations, especially regulations for labs
- Strong experience working in a lab setting to qualify a range of equipment/instruments like:
- HPLC
- / Headspace Sampler
- Microbalances / Analytical balances
- Centrifuges
- upgrading a piece of equipment to Windows 10
- Strong expertise in CSV (21 CFR Part 11) and GAMP5 for the Windows 10 upgrade and integration of other systems that generate electronic data
- Strong expertise reading User Requirements from vendors and translating them to protocols for qualification
- Experience communicating with equipment vendors
- Must be an expert in developing and executing validation protocols (IQ/OQ/PQs)
- Strong communication skills and a team player
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- Dice Id: 91123308
- Position Id: 8194650
Job tags
Salary
