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Validation Engineer

Bachem

Vista, USA

Mid

USD 84274-115877 / year

Discovered 1 weeks ago

Free

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Develop strategy, establish acceptance criteria, generate, execute cleaning validation protocols and reports
Perform, coordinate, execute and analyze cleaning recovery studies.
Lead cross-functional project teams to address issues and ensure on-time completion of all qualification / validation deliverables.
Provide qualification / validation guidance and strategy during project planning and development phases.
Train, coach and mentor team members.
Write validation protocols and final reports, test methods, standard operating procedures, and technical reports.
Planning, writing, and executing qualification protocols (DQ, IQ, OQ, PQ) and reports.
Independently conduct and document investigations related to validation studies.
Based on validation studies, evaluate and make recommendations for improvements to operations, processes and methods.
Accountable for the accuracy and validity of testing results
Support and assist with inspections and audits.
Plan and perform required periodic re-validation / re-qualification activities
Work and communicate with different associates within the company to ensure timely completion of assigned tasks and projects.
Adherence to cGMP and safety procedures and contribute to GMP systems improvements.
Perform other related duties as assigned.

Bachelor’s degree in science discipline (chemistry, biochemistry, biology or equivalent)
Master's degree (preferred)
5+ years of Commissioning, Qualification & Validation (CQV) / cleaning validation experience in a GMP/GDP environment
Experience with planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports
Experience with validation / monitoring of critical pharmaceutical utility systems, including purified water, nitrogen systems and cold storage units
Experience with planning and execution of cleaning validation of production lab glassware and equipment including performance of validation studies, writing validation protocols and reports and other technical documents, as well as conducting validation related investigations

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