Quality Engineer

Bachem
Vista, CA
Job Description
The Quality Engineer (QE) / Validation fulfills a critical role in GMP operations, supporting cleaning validation activities for API and PMO manufacturing, and the qualification of equipment, facilities, utilities.

Requirements

  • 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

Benefits

  • Competitive pay
  • Annual performance bonus
  • Generous benefit package
  • Comprehensive Medical/Dental/Vision coverage
  • 401(k) plan with employer contribution
  • Paid vacation, personal and sick days
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