Senior Engineer I, Validation

BeOne Medicines

Base: $109,900.00 - $149,900.00 annually; bonus/eq...
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5+ years biopharmaceutical validation experience
Cgmp knowledge and data integrity principles
Aseptic processing and sterile manufacturing expertise
** BeOne Medicines is seeking a Senior Engineer I for their Validation team to manage validation activities in a biopharmaceutical manufacturing environment. The ideal candidate will possess substantial experience in validation processes and compliance with cGMP regulations while supporting the company's mission to combat cancer. **

Job Summary

  • The role involves leading validation activities for equipment, processes, and products to ensure safety, quality, and regulatory compliance in a rapidly growing biotech environment.
  • Candidates must possess strong knowledge of cGMPs, risk assessments, and aseptic processing while managing projects on time and within budget.
  • The company offers a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for equity awards and annual bonuses.

Matching Summary

Match Score: 75

** BeOne Medicines is seeking a Senior Engineer I for their Validation team to manage validation activities in a biopharmaceutical manufacturing environment. The ideal candidate will possess substantial experience in validation processes and compliance with cGMP regulations while supporting the company's mission to combat cancer. **

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 biopharmaceutical validation experience
  • cGMP knowledge and Data Integrity principles
  • Aseptic processing and sterile manufacturing expertise
  • Equipment qualification (IQ/OQ/PQ) execution
  • Project planning and milestone management
  • SOP creation and review capabilities

Nice-to-have

  • Computerized System Validation (CSV) knowledge
  • Microsoft Project and Smartsheet proficiency
  • Veeva Vault or eQMS familiarity
  • Leadership and team collaboration skills
  • Proactive problem-solving attitude

Key Requirements

  • BS degree in engineering or related discipline OR 9 years relevant experience
  • Minimum 5 years validation experience with Bachelor's degree
  • Experience in FDA-regulated biotechnology or pharmaceutical companies

Work Rights

Not specified

Tailored Resume

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