What you will do

In this role you will be managing and leading all aspects of a device assembly & packaging line. Responsibility includes maintaining production in full cGMP compliance. Assist with supervising and developing technicians while overseeing production equipment to ensure production schedules are completed.

• 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

We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek will possess these qualifications.

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

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 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.)

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Salary Range