Senior Engineer I, Validation

beonemedicines.sg

Base: $109,900.00 - $149,900.00 annually; bonus/eq...
Site-based (requires gowning into manufacturing suites)
5 years validation experience
Cgmp regulatory compliance knowledge
Biotech sterile manufacturing background
BeOne Medicines is seeking a Senior Engineer I for their Validation function, focused on ensuring regulatory compliance and operational success in biopharmaceutical manufacturing. The role demands strong technical skills in validation processes, along with collaboration and effective communication

Job Summary

  • The role involves managing day-to-day validation activities to ensure successful execution of large projects while adhering to regulatory compliance.
  • Candidates must possess strong knowledge of cGMPs and have a proven track record in biopharmaceutical manufacturing or validation within an FDA-regulated environment.
  • BeOne Medicines offers a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for discretionary equity awards.

Matching Summary

Match Score: 85

BeOne Medicines is seeking a Senior Engineer I for their Validation function, focused on ensuring regulatory compliance and operational success in biopharmaceutical manufacturing. The role demands strong technical skills in validation processes, along with collaboration and effective communication.

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

Skills & Requirements

Must-have

  • 5 years validation experience
  • cGMP regulatory compliance knowledge
  • biotech sterile manufacturing background
  • equipment qualification and process validation
  • SOP creation and review capabilities

Nice-to-have

  • Computerized System Validation (CSV) knowledge
  • Microsoft Project and SAP proficiency
  • Strong leadership and communication skills
  • Risk-based approach to validation
  • Data integrity principles expertise

Key Requirements

  • BS degree in engineering or related discipline
  • Minimum 5 years relevant validation experience
  • Experience in biological quality assurance or QC
  • Knowledge of Data Integrity principles

Work Rights

Not specified

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