Senior Process Engineer
Amgen
2 hours ago
On-site
Holly Springs, NC
Operations
Senior Process Engineer
What You Will Do
- Join Facilities & Engineering (F&E) to partner with corporate engineering to design, build, commission, and qualify new equipment and systems for drug substance production.
- Develop domain expertise and system ownership supporting Upstream and Downstream process engineering and plant equipment.
Site design, construction, start-up, and operational readiness
- Support design/build of manufacturing equipment systems (equipment design & sizing, architecture & electrical distribution, piping and instrumentation diagrams).
- Support factory acceptance testing during site installation (review protocols; resolve punch list items).
- Work with capital project teams to ensure safe installation and compliance with environmental health/safety rules and regulations and Amgen global engineering requirements.
- Execute/guide commissioning and validation aligned with manufacturing requirements, GMP regulations, and on-time project delivery (including engineering and performance qualification runs and hypercare support).
- Perform engineering assessments; implement equipment modifications; support new product/technology introductions.
Site Operations
- Serve as system owner for Upstream and Downstream drug substance process equipment, areas, and systems (end-to-end operations support).
- Collaborate with Manufacturing, Quality, Process Development, Maintenance, and network partners to ensure reliable plant operations.
- Coordinate breakdown and planned maintenance with OEMs.
- Lead engineering-based equipment improvements/upgrades (business cases; translate requirements into design/specifications; support construction, startup, validation).
- Develop master maintenance programs; ensure spare parts availability; coordinate maintenance to keep systems operational.
- Ensure plant readiness and quality/regulatory compliance for audits (internal, external, and partner).
- Lead root cause analysis and corrective/preventive actions to proactively reduce production downtime.
- Lead new product/technology introductions (assessments; performance risk assessments; identify gaps; remediate; implement modifications; support engineering runs).
- Provide rotational on-call support; ensure 24x7 day-to-day reliability.
- Up to 10% domestic/international travel.
What We Expect Of You
Basic Qualifications
- High School Diploma/GED and 10 years of Engineering experience OR
- Associate’s Degree and 8 years of Engineering experience OR
- Bachelor’s Degree and 4 years of Engineering experience OR
- Master’s Degree and 2 years of Engineering experience OR
- Doctorate Degree
Preferred Qualifications / Skills
- Bachelor’s degree in Chemical or Mechanical Engineering.
- 6+ years relevant experience with 5+ years in biopharmaceutical operations/manufacturing.
- GMP biopharmaceutical production facility design/troubleshooting experience with Upstream/Downstream purification equipment (cell culture reactors, centrifugation, chromatography, viral filtration skids, UFDF skids) and supporting equipment (autoclaves, CIP, washers, clean steam, water for injection, etc.).
- Experience with Tech Transfer, Process Design, Commissioning & Qualification.
- Regulated environment experience (e.g., cGMP, OSHA, EPA) and familiarity with GMP quality systems/processes (change control, non-conformances, CAPA, qualifications/validation).
- Understanding of safety requirements in GMP biopharmaceutical production facilities.
- Independent, ambitious, organized; able to multi-task; strong communication/facilitation/teamwork.
- Strong leadership, technical writing, and presentation/communication skills.
- Schedule flexibility for 24/7 operations.
- Ability to travel domestically/internationally.
Application Instructions
- Apply now at careers.amgen.com.
What You Will Do
- Join Facilities & Engineering (F&E) to partner with corporate engineering to design, build, commission, and qualify new equipment and systems for drug substance production.
- Develop domain expertise and system ownership supporting Upstream and Downstream process engineering and plant equipment.
Site design, construction, start-up, and operational readiness
- Support design/build of manufacturing equipment systems (equipment design & sizing, architecture & electrical distribution, piping and instrumentation diagrams).
- Support factory acceptance testing during site installation (review protocols; resolve punch list items).
- Work with capital project teams to ensure safe installation and compliance with environmental health/safety rules and regulations and Amgen global engineering requirements.
- Execute/guide commissioning and validation aligned with manufacturing requirements, GMP regulations, and on-time project delivery (including engineering and performance qualification runs and hypercare support).
- Perform engineering assessments; implement equipment modifications; support new product/technology introductions.
Site Operations
- Serve as system owner for Upstream and Downstream drug substance process equipment, areas, and systems (end-to-end operations support).
- Collaborate with Manufacturing, Quality, Process Development, Maintenance, and network partners to ensure reliable plant operations.
- Coordinate breakdown and planned maintenance with OEMs.
- Lead engineering-based equipment improvements/upgrades (business cases; translate requirements into design/specifications; support construction, startup, validation).
- Develop master maintenance programs; ensure spare parts availability; coordinate maintenance to keep systems operational.
- Ensure plant readiness and quality/regulatory compliance for audits (internal, external, and partner).
- Lead root cause analysis and corrective/preventive actions to proactively reduce production downtime.
- Lead new product/technology introductions (assessments; performance risk assessments; identify gaps; remediate; implement modifications; support engineering runs).
- Provide rotational on-call support; ensure 24x7 day-to-day reliability.
- Up to 10% domestic/international travel.
What We Expect Of You
Basic Qualifications
- High School Diploma/GED and 10 years of Engineering experience OR
- Associate’s Degree and 8 years of Engineering experience OR
- Bachelor’s Degree and 4 years of Engineering experience OR
- Master’s Degree and 2 years of Engineering experience OR
- Doctorate Degree
Preferred Qualifications / Skills
- Bachelor’s degree in Chemical or Mechanical Engineering.
- 6+ years relevant experience with 5+ years in biopharmaceutical operations/manufacturing.
- GMP biopharmaceutical production facility design/troubleshooting experience with Upstream/Downstream purification equipment (cell culture reactors, centrifugation, chromatography, viral filtration skids, UFDF skids) and supporting equipment (autoclaves, CIP, washers, clean steam, water for injection, etc.).
- Experience with Tech Transfer, Process Design, Commissioning & Qualification.
- Regulated environment experience (e.g., cGMP, OSHA, EPA) and familiarity with GMP quality systems/processes (change control, non-conformances, CAPA, qualifications/validation).
- Understanding of safety requirements in GMP biopharmaceutical production facilities.
- Independent, ambitious, organized; able to multi-task; strong communication/facilitation/teamwork.
- Strong leadership, technical writing, and presentation/communication skills.
- Schedule flexibility for 24/7 operations.
- Ability to travel domestically/internationally.
Application Instructions
- Apply now at careers.amgen.com.