Manufacturing Engineering Support Specialist

About the role

Amgen is hiring a Specialist in Manufacturing Engineering Support. The role supports the manufacturing team and provides technical expertise in a GMP-regulated environment, covering documentation such as SOPs, work instructions, protocols and training material, and owning quality records such as deviations, CAPAs, change controls and Quality Risk Management.

Key responsibilities

• Develop, review and update technical content including SOPs, WIs, risk assessments, protocols and reports for the manufacturing team.
• Generate, own and provide subject matter expertise for Quality System records such as minor/major deviations, CAPA and change control records.
• Provide technical and clerical support for documentation, data collation and tracking of technical documents.
• Liaise with the manufacturing team and other departments on documentation changes, and support new or revised training documentation.
• Support process owners in continuous improvement and troubleshooting projects, and help reduce document turnaround times.
• Develop protocols for manufacturing change controls, deviations and troubleshooting investigations, and track pending change control activities.
• Work with Quality Assurance to maintain GMP standards and share knowledge with the manufacturing team.

Required profile

• Basic qualification: doctorate; or master's degree with 2 years of engineering, manufacturing, packaging or quality experience in pharma, medical devices or biotechnology; or bachelor's degree with 4 years of such experience; or associate's degree with 8 years of such experience; or high school diploma / GED with 10 years of such experience.
• Preferred: science or engineering education, GMP experience, technical writing background, and experience supporting deviations, investigations, CAPAs and change controls.

Required skills

• Solid background in technical writing and ability to explain complex technical information clearly to manufacturing operators.
• Use of photographs, drawings, diagrams, animation and charts to improve understanding.
• Strong troubleshooting, prioritization, documentation and communication skills.

What we offer

• Base salary of $107,545.40 to $145,502.60, plus a Total Rewards Plan.
• Health, dental and vision coverage, life and disability insurance, retirement savings plan with company contributions, and flexible spending accounts.
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives, and time-off plans.
• Flexible work models where possible.