This Senior Associate Manufacturing position will coordinate and lead production operations on the manufacturing floor including taking a lead role in the qualification of process equipment as the new facility is started up.
The initial focus of this role will be part of the AR30 startup team. This includes and not limited to support interviewing of manufacturing operations team, develop training, SOPs, electronic batch records, job hazards analysis, and standard work. Participate in commissioning and qualification of process equipment.
The shift pattern will be a 7PM - 7AM structure with a rotation covering 7 nights per week. The rotating 12-hour night shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, the night shift is eligible for a shift differential and any Sundays worked receive Premium pay.
There are two openings for this position. Target hire start date is January 2020.
Lead manufacturing operations on the production floor.
Ensure all safety and compliance procedures are always followed.
Participate in the development, execution, and issue resolution associated with process equipment Commissioning, Qualification and Validation.
Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.
Write, revise, and own controlled documentation (SOPs), Forms, Technical Reports, etc.)
Serve as SME for Cell Culture and/or Purification operations.
Provide training to manufacturing staff on process and equipment.
Own Deviations and Corrective and Preventive Actions (CAPA)
Champion Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in all Manufacturing areas.
Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve manufacturing events in a timely manner.
Assure appropriate escalation to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
Collaborate with Quality, Manufacturing Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams.
Participate in the design, development, and implementation of processes in support of the manufacturing floor.
Bachelor's degree and 2 years of Manufacturing or Operations experience
Associate's degree and 6 years of Manufacturing or Operations experience
High school diploma / GED and 8 years of Manufacturing or Operations experience
Bachelor's degree in Science or Engineering
Knowledge of cell culture operations and bioreactors or purification process
Knowledge of analytical equipment and computers
CFR and Regulatory knowledge
Mechanical aptitude with ability and expertise
Independently collaborate with outside resources
Basic statistical mathematical skills
Ability to interpret and apply GMP knowledge
Understanding of analytical methods for manufacturing area
Ability to demonstrate technical writing capability
Ability to understand, apply and evaluate basic chemistry, biology and physical principles
Troubleshooting skills on process equipment
Ability to lead teams
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Associated topics: bio, biological engineer, biomedical, biosynthetic, genetic, hereditary, metabolic, neuro, nutrition, therapeutic
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.