Senior Associate ManufacturingManufacturing Investigations

HOW MIGHT YOU DEFY IMAGINATION? If you feel likeyourepart of something bigger,its because you are. At Amgen, our shared missionto serve patients drives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve together researching, manufacturing, anddeliveringever-better products that reach over
10 million patients worldwide.

Itstime for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen Fle Xbatch  facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations TheFleXBatch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Live

• Managesimpledeviationand environmental monitoringinvestigations,specifically within theControlled
  
  Environmental Monitoring space, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
• Apply a basic understanding of microbiology principles, environmental monitoring programs, and contamination control strategies to support environmental monitoring investigations.
• Interpret environmental monitoring data,identify trends, and assess potential impactstoproduct quality, manufacturing operations, and contamination control programs.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Clearly communicate investigation progress toimpactedareas and leadership.
• Coordinate and effectively lead cross-functional teams through investigations, and complete milestones on-schedule.
• Present investigation findings and technical information to diverse audiences and communicate moderately complex issues in a clear and concise manner.
  
  Build effective relationships across functions.
• Navigate through ambiguity and provide a structured problem-solving approach.
• Apply inductive and deductive reasoning in the investigation process
• Clear and concise technical writing
• Use Operational Learning Team  strategies topromote open collaboration with stafftomaximizeinvestigation findings.
• Developtracking tools to ensure on-time closure and proactivereviewof deviation investigations.
• Win

We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator weseekhas a biologics Drug Substancemanufacturingandmicrobiologicalinvestigationsbackground with strong cross-functional project management and communication skills as well as the below qualifications.

• High School Diploma /GED + 4yearsmanufacturing and/orotherregulatedenvironmentexperience
• Or
• Associates Degree+ 2 years manufacturing and/orotherregulated environment experience
• Or
• Bachelors Degree+ 6 monthsmanufacturing and/orotherregulatedenvironmentexperience
• Or
• Master'sDegree

• 3+ years related work experience (manufacturing,microbiology, process development,or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
• Basic understanding of Drug Substance manufacturing, environmental monitoring programs, and contamination control principles.
• Experience with compliance, problem-solving,simple and complexroot cause analysis tools (5-whys, fishboneetc.)critical thinking, project management, and quality systems.
• Degree in Science or Engineering(Microbiology or similar a plus)
• Experience leading investigations
• Experience using
  
  VeevaQMSfor Deviation investigations and CAPAs
• Demonstrated project management ability
• Excellent written and verbal communication skills
• Ability to work in a team matrix environment and build relationships with partners
• Strong interpersonal skills
• Thrive

In Addition To The Base Salary, Amgen Offers a Total Rewards Plancomprisinghealth 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 Including

• 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…