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Process Supervisor – Chemical Engineering Research & Development
| Company | Merck |
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| Location | Linden, NJ, USA |
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| Salary | $85600 – $134800 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Mid Level |
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Requirements
- Bachelor’s degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline with at least 2 years of relevant experience in a process development lab, pilot plant/manufacturing facility, or other operations environment.
- OR High school diploma with at least 6 years of relevant experience in a process development lab or pilot plant/manufacturing facility.
- Mechanical aptitude and familiarity with chemical process development and process equipment.
- Understanding of and experience with current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and Safety & Environmental (S&E) regulations.
- Experience operating/maintaining pilot scale or prep lab scale equipment.
- Effective communication skills and a collaborative mindset.
- Experience in conflict resolution and root cause analyses.
- Ability to build effective work relationships with a diverse workforce.
- Adaptable to a dynamic production environment.
- Relevant experience in a process development lab or pilot plant/manufacturing facility.
- As the building transitions towards equipment qualifications and operations must be able to rotate between 1st and 2nd shift on a weekly basis.
- Desire and willingness to learn, contribute and lead.
- Experience with coordinating maintenance activities around processing activities to support reliable facility operation.
- Experience working in an environment with Automation Systems (DeltaV, PLC, etc.).
Responsibilities
- Supervise and participate in daily production activities while ensuring compliance with Safety, GMP, and Environmental requirements to meet MACS objectives and customer requirements.
- Implement process improvement actions to meet S&E (Safety & Environmental) and GMP requirements.
- Ensure facility readiness for API (Active Pharmaceutical Ingredient) processing and share accountability for the building performance.
- Work cooperatively with the MACS leadership team and cross-functional MACS partners to drive overall success and performance of the building.
- Prioritize and assign daily activities for the operations staff.
Preferred Qualifications
- Experience supervising a team of shop floor personnel in an operations environment
- Experience with GMP facility design, equipment start-up and/or qualification.
- Experience with small molecule drug substance and/or biologics process development.
- Experience in supporting compliance investigations and change management.
- Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA)
- Experience with Potent Compound processing and containment systems (e.g., isolators).
- Experience interacting with process utility system associated with a large drug substance pilot plant including WFI generation/distribution, Process Chillers, Vacuum Systems, etc.
