Senior Process Engineer - Solution Prep, Upstream, and Downstream
Amgen
July 01, 2026
On-site
Holly Springs, NC
Operations
Senior Process Engineer - Solution Prep, Upstream, and Downstream
What You Will Do
- Design, build, commission, and qualify new equipment and systems needed for drug substance production (Solution Prep, Upstream, Downstream).
- Support design/build of manufacturing equipment systems (equipment sizing, architecture/electrical distribution, piping & instrumentation diagrams).
- Support factory acceptance testing during site installation (review protocols, resolve punch list items).
- Ensure safe installation and compliance with environmental health/safety rules and Amgen engineering requirements.
- Execute/guide commissioning and validation to meet GMP requirements; support engineering and performance qualification runs and hypercare.
- Perform engineering assessments, implement equipment modifications, and support engineering runs for new product/technology introductions.
Site Operations
- Serve as system owner for Solution Prep, Upstream, Downstream equipment/areas; provide end-to-end operational support.
- Collaborate with Manufacturing, Quality, Process Development, Maintenance, and network partners for reliable plant operations.
- Coordinate breakdown/planned maintenance with OEMs.
- Lead engineering improvements/upgrades (business cases, design requirements, translation into equipment/system specs, construction/startup/validation support).
- Develop master maintenance programs; ensure spare parts availability.
- Support internal/external/partner audits for process equipment readiness, quality, and regulatory compliance.
- Lead technical root cause analysis and corrective/preventive actions to reduce downtime.
- Lead technology introductions via assessments, performance risk assessments, remediation ownership, and modifications.
- Provide rotational on-call and/or shift support for 24/7 reliability; on-site travel up to 10%.
What We Expect Of You
Basic Qualifications
- Doctorate degree OR
- Master’s + 2 years engineering experience OR
- Bachelor’s + 4 years engineering experience OR
- Associate’s + 8 years engineering experience OR
- High school diploma/GED + 10 years engineering experience
Preferred Qualifications
- Degree in Chemical/Mechanical Engineering (or similar).
- 6+ years relevant experience; 5+ years in biopharmaceutical operations/manufacturing.
- GMP biopharmaceutical production equipment/system design & troubleshooting; experience with Solution Prep/Upstream/Downstream purification (e.g., weigh/dispense, solution prep vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, UFDF skids; plus autoclaves, CIP, washers, clean steam, water for injection).
- Tech Transfer, process design, commissioning & qualification.
- Regulated environment experience (cGMP, OSHA, EPA) and GMP quality systems (change control, non-conformances, CAPA, validation/qualification).
- Safety knowledge for GMP biopharmaceutical production.
- Strong leadership, technical writing, communication/presentation, organization, and teamwork.
- Flexibility for 24/7 operations; domestic/international travel ability.
What You Will Do
- Design, build, commission, and qualify new equipment and systems needed for drug substance production (Solution Prep, Upstream, Downstream).
- Support design/build of manufacturing equipment systems (equipment sizing, architecture/electrical distribution, piping & instrumentation diagrams).
- Support factory acceptance testing during site installation (review protocols, resolve punch list items).
- Ensure safe installation and compliance with environmental health/safety rules and Amgen engineering requirements.
- Execute/guide commissioning and validation to meet GMP requirements; support engineering and performance qualification runs and hypercare.
- Perform engineering assessments, implement equipment modifications, and support engineering runs for new product/technology introductions.
Site Operations
- Serve as system owner for Solution Prep, Upstream, Downstream equipment/areas; provide end-to-end operational support.
- Collaborate with Manufacturing, Quality, Process Development, Maintenance, and network partners for reliable plant operations.
- Coordinate breakdown/planned maintenance with OEMs.
- Lead engineering improvements/upgrades (business cases, design requirements, translation into equipment/system specs, construction/startup/validation support).
- Develop master maintenance programs; ensure spare parts availability.
- Support internal/external/partner audits for process equipment readiness, quality, and regulatory compliance.
- Lead technical root cause analysis and corrective/preventive actions to reduce downtime.
- Lead technology introductions via assessments, performance risk assessments, remediation ownership, and modifications.
- Provide rotational on-call and/or shift support for 24/7 reliability; on-site travel up to 10%.
What We Expect Of You
Basic Qualifications
- Doctorate degree OR
- Master’s + 2 years engineering experience OR
- Bachelor’s + 4 years engineering experience OR
- Associate’s + 8 years engineering experience OR
- High school diploma/GED + 10 years engineering experience
Preferred Qualifications
- Degree in Chemical/Mechanical Engineering (or similar).
- 6+ years relevant experience; 5+ years in biopharmaceutical operations/manufacturing.
- GMP biopharmaceutical production equipment/system design & troubleshooting; experience with Solution Prep/Upstream/Downstream purification (e.g., weigh/dispense, solution prep vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, UFDF skids; plus autoclaves, CIP, washers, clean steam, water for injection).
- Tech Transfer, process design, commissioning & qualification.
- Regulated environment experience (cGMP, OSHA, EPA) and GMP quality systems (change control, non-conformances, CAPA, validation/qualification).
- Safety knowledge for GMP biopharmaceutical production.
- Strong leadership, technical writing, communication/presentation, organization, and teamwork.
- Flexibility for 24/7 operations; domestic/international travel ability.