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At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll 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 youll 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
Lets do this. Lets 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.
Additional Qualifications/ResponsibilitiesWhat 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
Associates 2 years biotech or pharmaceutical manufacturing process development or quality experience
Or
Bachelors 6 months biotech or pharmaceutical manufacturing process development or quality experience work experience
Or
Masters
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
As 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 well 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
Salary Range
88378.00 USD - 106188.00 USD