Scientist – Validation Engineering focused on the areas below.
- Responsible for independently providing technical support to Operations in terms of system qualification and optimization for pertinent applications. May participate in cross-functional equipment procurement teams and change control projects to enhance the compliance and performance of qualified GMP systems.
- Write Equipment Qualification documents and approaches. This includes: Master Validation Plans, Failure Mode and Effects Analysis, Sampling Plans, Equipment qualification documents (IQ, OQ, and PQ), and Optimization studies and approaches.
- Coordinate and communicate all testing with affected functional groups and procure resources, materials, and testing vendors. Execute equipment validation studies, documenting and investigating deviations, evaluating test results, and composing summary report for approval.
- Optimize equipment for specific and general applications.
- Qualify systems with embedded process controllers as they relate to production equipment.
- Program and operate department analytical instruments (such as temperature/humidity dataloggers) to perform environmental control studies.
- Support the Operations team by performing investigations for exception reports. This includes determining the product impact, root cause and any follow-up activities.
- Write and contribute to enhancement of departmental SOP’s and Guidelines.
- Participate in various presentations, enhancements, troubleshooting, and maintenance of systems and equipment.
- Bachelor’s degree in a scientific or technical field (chemistry, engineering, chemical engineering, life science) and a minimum of 4+ years of experience working in the pharmaceutical industry OR Master’s degree in a scientific or technical field and a minimum of 2+ years of experience working in the pharmaceutical industry.
- Experience with oral solid dosage and equipment qualification.
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