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BeOne Medicines is seeking a Senior Engineer I in Validation to support their biopharmaceutical manufacturing operations. The successful candidate will manage validation activities, ensuring compliance with regulatory standards while contributing to the company's mission of fighting cancer.
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Job Summary
This role supports the facility's validation function to ensure successful management of large projects while adhering to regulatory compliance.
The position requires developing and approving critical cGMP documents including Master Validation Plans, protocols, and reports for equipment and processes.
BeOne Medicines offers a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for equity awards.
Matching Summary
Match Score: 75
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BeOne Medicines is seeking a Senior Engineer I in Validation to support their biopharmaceutical manufacturing operations. The successful candidate will manage validation activities, ensuring compliance with regulatory standards while contributing to the company's mission of fighting cancer.
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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 regulatory compliance knowledge
Equipment qualification and process validation
Aseptic processing and sterile manufacturing
Risk assessment and deviation investigation
Nice-to-have
Computerized System Validation (CSV) expertise
Microsoft Project and SAP working knowledge
Strong leadership and communication skills
Data integrity principles application
Collaborative team spirit and proactive attitude
Key Requirements
BS or higher in engineering or related discipline
Minimum 5 years relevant experience in biopharma validation
Scientific degree in pharmaceutical sciences, engineering, or chemistry