Sr. Associate, Manufacturing 12 hour Shift - New Albany, OH

Sr. Associate, Manufacturing 12 Hour Shift - New Albany, OH

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps.

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areasOncology, Inflammation, General Medicine, and Rare Diseasewe reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Manufacturing Senior Associate

What you will do:

• Manage and lead all aspects of a device assembly & packaging line
• Maintain production in full cGMP compliance
• Assist with supervising and developing technicians while overseeing production equipment
• 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
• Escalate 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

What we expect of you:

• Basic Qualifications:
• High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience
• Or Associate's + 2 years biotech or pharmaceutical manufacturing, process development or quality experience
• Or Bachelor's + 6 months biotech or pharmaceutical manufacturing, process development or quality experience work experience
• Preferred Qualifications:
• Degree in Chemical Engineering, Industrial Engineering or Life Sciences
• Technical understanding of pharmaceutical/biotech packaging equipment and processes
• Experience with Current Good Manufacturing Practices (cGMP)
• Ability to be flexible and manage change
• Experience participating in and leading cross-functional teams
• Experience in managing multiple, competing priorities in a fast-paced environment
• Strong scientific, technical interactions with partner organizations such as PD and F&E
• Experience in GMP Tech Support roles, GMP operations, process development or scheduling
• Experience with Commissioning and Qualification, New Product Introduction, Cleaning Validation, and Process Performance Qualification
• Ability to organize, analyze, and interpret technical data that is impacting operations
• Background in lean manufacturing methodologies and operational excellence
• Expertise in electronic systems used in manufacturing (MES, LIMS, Maximo, CCMS, SAP, etc.)

What you can expect of us:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible
• Salary Range $88,378.00 USD - $106,188.00 USD

Location: New Albany, Ohio

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