Process Equipment Engineer II - Small Molecule GMP
BeiGene, Ltd.
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Job summary
BeOne Medicines seeks an Engineer II Process Equipment Engineer for the Hopewell, NJ site to support a new Small Molecule facility and ensure a stable GMP manufacturing operation. You will work independently with limited supervision and coordinate with manufacturing and quality teams to meet 24x7 production needs.
You will provide SME input for equipment and facility commissioning, qualification, and validation, develop procedures, and maintain preventive maintenance plans while collaborating
Qualifications
- BS or higher in engineering and/or related discipline with GMP pharmaceutical experience.
- Minimum 4+ years of equipment and facility support in GMP environment.
- Experience with commissioning, qualification, and validation of systems.
- Strong written and verbal communication across cross-functional teams.
- Experience with CMMS, Metrology, and facility maintenance.
Responsibilities
- Provide SME input into equipment and facilities for Small Molecule projects.
- Lead commissioning/qualification/validation activities for responsible systems.
- Develop and maintain SOPs and preventive maintenance plans.
- Collaborate with Global Engineering to meet milestones and KPIs.
- Support operations with troubleshooting and issue resolution for equipment, facilities, and utilities.
- Lead fault analysis and remediation as needed.
Skills
Education
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Job description
BeOne Medicines seeks an Engineer II Process Equipment Engineer for the Hopewell, NJ site to support a new Small Molecule facility and ensure a stable GMP manufacturing operation. You will work independently with limited supervision and coordinate with manufacturing and quality teams to meet 24x7 production needs.
You will provide SME input for equipment and facility commissioning, qualification, and validation, develop procedures, and maintain preventive maintenance plans while collaborating
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