Senior Engineer I, Validation

beonemedicines.ar

Base: $109,900.00 - $149,900.00 annually; bonus/eq...
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Cgmp documents
Validation activities
Risk assessments
** BeOne Medicines is seeking a Senior Engineer I in Validation to manage validation activities within a biopharmaceutical manufacturing setting. The ideal candidate will have significant experience in cGMP compliance and validation processes, with a strong emphasis on collaboration and problem-solving. **

Job Summary

  • Engages in the day-to-day activities of the Validation function, ensuring the successful management of related activities and large projects.
  • Develop and approve cGMP documents including, but not limited to: Equipment and instrument Qualification, Commissioning, Master Validation Plans, SOP’s, Comparability reports, Aseptic Process simulation protocols and reports; process validation (PPQ), and cleaning/sterilization validation.
  • The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Matching Summary

Match Score: 75

** BeOne Medicines is seeking a Senior Engineer I in Validation to manage validation activities within a biopharmaceutical manufacturing setting. The ideal candidate will have significant experience in cGMP compliance and validation processes, with a strong emphasis on collaboration and problem-solving. **

Salary

Base: $109,900.00 - $149,900.00 annually; Bonus/Equity: Eligible for annual bonus plan; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • cGMP documents
  • validation activities
  • risk assessments
  • biotech manufacturing
  • aseptic processing
  • validation sample management
  • investigation of discrepancies

Nice-to-have

  • collaborative
  • highly motivated
  • passionate interest
  • customer focused
  • hands-on approach
  • can do attitude
  • proactively using own initiative

Key Requirements

  • BS or higher in engineering and/or related discipline OR minimum 9 years relevant experience
  • Minimum 5 years biopharmaceutical manufacturing, engineering, and/or validation
  • Minimum 5 years validation (Bachelors) or 4 years (Masters)
  • Knowledge of cGMPs and Data Integrity principles
  • Biotech and/or Sterile manufacturing and aseptic processing knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter