Senior Engineer I, Validation

BeOne Medicines Ltd

Hopewell, US
Base: $109,900.00 - $149,900.00 annually; bonus/eq...
On-site
Cgmp documents development and approval
Lead validation activities for projects
Biotech and/or sterile manufacturing knowledge
BeOne Medicines Ltd is seeking a Senior Engineer I in Validation for their Hopewell, US location. The role involves managing validation activities in a biopharmaceutical manufacturing setting while ensuring regulatory compliance and supporting operational objectives

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 offers a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Matching Summary

Match Score: 85

BeOne Medicines Ltd is seeking a Senior Engineer I in Validation for their Hopewell, US location. The role involves managing validation activities in a biopharmaceutical manufacturing setting while ensuring regulatory compliance and supporting operational objectives.

Salary

Base: $109,900.00 - $149,900.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness

Skills & Requirements

Must-have

  • cGMP documents development and approval
  • Lead validation activities for projects
  • Biotech and/or Sterile manufacturing knowledge
  • Risk assessments and process knowledge
  • Data Integrity principles

Nice-to-have

  • Customer focused with a 'can do' attitude
  • Proactive and self-motivated work style
  • Collaborative spirit and teamwork

Key Requirements

  • BS or higher in engineering and/or related discipline OR a minimum of 9 years relevant experience
  • Minimum 5 years of experience in biopharmaceutical manufacturing, engineering, and/or validation
  • Minimum of 5 years’ experience in validation (with Bachelors degree) or 4 years (with a Masters degree)

Work Rights

Not specified

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