Specialist Mfg I
About The Position
Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives 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 areas –Oncology, Inflammation, General Medicine, and Rare Disease– we 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.
Requirements
- Create and manage change control records in Veeva/CDOCs systems
- Own change control records to support Manufacturing/NPI programs or other parallel projects
- Create and update Manufacturing documents/revision of process Bill of Materials (BOM) in Veeva/CDOCs, additionally support new Smart BOM project in Smartsheet’s
- Management of manufacturing document workflows in CDOCs/Veeva
- Experience in critical manufacturing operations, continuous improvement, CAPA and Deviation
- Technical Expertise on mechanical and automated functionality of systems impacted by Manufacturing/NPI project including chromatography, Harvest through DeltaV
- Utilize expertise to troubleshoot issues through DeltaV, PI Vision and Spotfire
- Support management of cross functional deliverables to meet project timelines as managed through Veeva and Smartsheets
- Facilitate Microsoft Teams and in person meetings associated with NPI programs
Responsibilities
- Lead and support planning and execution of key initiatives with cross functional teams at the production floor
- Liaison at the floor and with cross function teams to assure program (NPI/PRI) preparation, implementation, sustainment and capture and share lessons learned
- Provide and analyzes data to support management evaluation of process performance trends
- Provide subject matter expertise for area of responsibility
- Own quality records (change control, CAPA, deviations) and deliver to timelines
- Support AR5/AR30 manufacturing organizations in the prioritization and execution of these activities to maximize plant performance and plant capacity
- Collaborate with Quality, Process Engineering, Regulatory, and Process Development to implement process improvements
- Support of front-line managers through on the floor presence
- Own and author critical standard operating procedures and supporting documentation/training
- Anticipate risk and builds contingencies to help mitigate impact
Benefits
- stock
- retirement
- medical
- life and disability insurance
- eligibility for an annual bonus or for sales roles, other incentive compensation
- Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
