Senior Engineer I, Validation

BeOne Medicines

Base: $109,900.00 - $149,900.00 annually; bonus/eq...
Onsite
5+ years validation experience in biopharma
Cgmp knowledge and data integrity principles
Experience with equipment qualification and process validation
BeOne Medicines is seeking a Senior Engineer I for their Validation function, focusing on ensuring regulatory compliance and supporting operational objectives in a biopharmaceutical manufacturing environment. The position requires significant experience in validation within FDA-regulated settings and a strong understanding of cGMP standards

Job Summary

  • The role involves ensuring the Validation function supports operational needs while adhering to strict regulatory compliance requirements.
  • Candidates will be responsible for developing and approving cGMP documents including Master Validation Plans, SOPs, and Process Validation reports.
  • BeOne Medicines offers a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for equity ownership.

Matching Summary

Match Score: 85

BeOne Medicines is seeking a Senior Engineer I for their Validation function, focusing on ensuring regulatory compliance and supporting operational objectives in a biopharmaceutical manufacturing environment. The position requires significant experience in validation within FDA-regulated settings and a strong understanding of cGMP standards.

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 in biopharma
  • cGMP knowledge and Data Integrity principles
  • Experience with equipment qualification and process validation
  • Knowledge of aseptic processing and sterile manufacturing
  • Ability to lead FAT, SAT, IQ, OQ, PQ activities

Nice-to-have

  • Strong leadership and communication skills
  • Experience managing validation consultants
  • Proactive problem-solving attitude
  • Familiarity with SAP or Veeva Vault systems
  • Collaborative spirit and team-focused mindset

Key Requirements

  • BS or higher in engineering or related discipline
  • Minimum 5 years experience in biopharmaceutical validation
  • Progressive responsibility in FDA-regulated environments

Work Rights

Not specified

Tailored Resume

Cover Letter