Career CategoryManufacturing
Job DescriptionManufacturing Senior AssociateWhat you will doLet's do this. Let's change the world. 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 youWe 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.)
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- 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
Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.
careers.amgen.comSponsorshipSponsorship for this role is not guaranteed.
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