Manufacturing Senior Associate (3rd shift 10:30pm-7am)
Amgen
Full-time
Remote friendly (New Albany, OH)
United States
Operations
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Role Summary
Manufacturing Senior Associate (3rd shift 10:30pm-7am)
Responsibilities
- Lead manufacturing operations on the production floor while helping to perform equipment setup, operation and troubleshooting.
- Maintain machine uptime, perform any fault clearing and clear stoppages on automated equipment.
- Ensure all safety and compliance procedures are followed at all times.
- Raise appropriate concerns to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
- Provide training to manufacturing staff on process and equipment.
- Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.
- Collaborate with Quality, Engineering and Manufacturing Support to resolve manufacturing events in a timely manner.
- Support Deviation Triage and Corrective and Preventive Actions (CAPA) processes
- Write, review & revise controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc)
- Apply process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to support manufacturing operations.
- Champion Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in the plant.
- Participate in the design, development, and implementation of processes in support of the manufacturing floor.
- Participate in the development, implementation, and issue resolution associated with process equipment Commissioning, Qualification and Validation
- Collaborate with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams.
Qualifications
- Basic Qualifications: High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience; Or Associate’s + 2 years; Or Bachelor’s + 6 months; Or Master’s
- Preferred Qualifications: Degree in Chemical Engineering, Industrial Engineering or Life Sciences; Technical understanding of pharmaceutical/biotech packaging equipment and processes; Experience with cGMP; Ability to be flexible and manage change; Experience participating in and leading cross-functional teams