Specialist - Manufacturing - Engineering Support

About the role

Amgen’s mission is to serve patients living with serious illnesses. Since 1980 the company has pioneered biotech across therapeutic areas including Oncology, Inflammation, General Medicine, and Rare Disease. As a member of the manufacturing team you will support the manufacturing process in a GMP‑regulated environment by drafting and revising Standard Operating Procedures, Work Instructions, protocols, technical reports, and training material, as well as leading quality records such as deviations, CAPAs, Change Controls, and Quality Risk Management.

Responsibilities

• Develop, review, and update technical content including but not limited to SOPs, WIs, risk assessments, protocols & reports for the manufacturing team.
• Generate, own, and provide subject‑matter expertise to Quality System records such as minor/major deviations, CAPA, and change‑control records.
• Provide technical and clerical support to the manufacturing team in the preparation of documentation, collation of data, and tracking of technical documents.
• Liaise with the manufacturing team and other cross‑functional departments regarding documentation changes in an effective and timely manner.
• Collaborate with multiple departments to support new or revised training documentation for manufacturing staff.
• Support process owners and participate in continuous process improvement and/or troubleshooting projects.
• Support the manufacturing team in reducing document turnaround times.
• Ensure documentation‑related actions are completed on time and that the current schedule is maintained, accurate, and up to date.
• Develop protocols for execution in manufacturing to support change controls, deviations, and troubleshooting investigations with input from relevant SMEs.
• Track pending activities required to support change‑control implementations.
• Liaise with Quality Assurance to ensure GMP standards are maintained in line with current operating systems.
• Share knowledge with members of the manufacturing team.

Basic Qualifications

• Doctorate degree, or Master’s degree with 2 years of Engineering, Manufacturing, Packaging, or Quality experience in pharmaceutical, medical‑device, or biotechnology companies.
• Bachelor’s degree with 4 years of Engineering, Manufacturing, Packaging, or Quality experience in pharmaceutical, medical‑device, or biotechnology companies.
• Associate’s degree with 8 years of Engineering, Manufacturing, Packaging, or Quality experience in pharmaceutical, medical‑device, or biotechnology companies.
• High school diploma / GED with 10 years of Engineering, Manufacturing, Packaging, or Quality experience in pharmaceutical, medical‑device, or biotechnology companies.

Preferred Qualifications

• Educational background in Science and/or Engineering.
• Experience working in GMP pharma and/or biotechnology industry.
• Experience in a Good Manufacturing Practices (GMP) environment and solid background in technical writing.
• Experience with device assembly and packaging of final product.
• Ability to translate highly technical information into easily understandable information for manufacturing operators.
• Creative skills and use of photographs, drawings, diagrams, animation, and charts that increase user understanding.
• Experience supporting deviations, investigations, CAPAs, and change controls.
• Fact‑based problem solver with strong troubleshooting and problem‑solving skills.
• Pro‑active, result‑driven, and able to prioritize work to meet deadlines.
• Good documentation and communication skills.

Benefits

• Competitive base salary plus