Process Engineer - Solution Prep, Upstream, and Downstream
Amgen
July 01, 2026
On-site
Holly Springs, NC
Operations
Process Engineer - Solution Prep, Upstream, and Downstream
What You Will Do
- Partner with corporate engineering to design, build, commission, and qualify new equipment and systems for drug substance production; develop domain expertise to support operations upon start-up.
- Support commissioning/qualification of manufacturing systems aligned with GMP requirements; interact with regulatory inspectors.
- Ensure safe installation/operation and compliance with environmental health/safety rules and regulations.
- Support system commissioning/qualification to meet manufacturing requirements and GMP.
- As a manufacturing systems owner, communicate and demonstrate regulatory compliance.
- Support new product/technology introductions via engineering assessments, equipment modifications, and engineering runs.
Site Operations
- Provide system support for biopharmaceutical process equipment; identify and implement engineering improvements/upgrades.
- Develop business cases; translate design requirements into equipment/system design, specifications, and support construction, startup, and validation.
- Develop maintenance programs, ensure spare parts availability, and coordinate maintenance.
- Identify performance risks and implement risk reduction strategies.
- Provide problem-solving support to reduce downtime; support technical root cause analysis and corrective/preventive actions.
- Provide rotational on-call/shift support for 24x7 reliability.
- On-site and up to 10% domestic/international travel.
Basic Qualifications
- Master’s degree
OR Bachelor’s degree + 2 years engineering experience
OR Associate’s degree + 6 years engineering experience
OR High school diploma/GED + 8 years engineering experience
Preferred Qualifications / Skills
- BS Chemical/Mechanical Engineering (or similar).
- 3+ years relevant experience; 2+ years in biopharmaceutical operations/manufacturing.
- Direct GMP biopharmaceutical facility equipment/system design & troubleshooting; experience with Solution Prep/Upstream/Downstream purification equipment (e.g., weigh & dispense, solution prep vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, UFDF skids) and support equipment (autoclaves, CIP, washers, clean steam, water for injection, etc.).
- Data-driven problem solving (Data Analytics, RCA, SPC, Six Sigma, Predictive Maintenance).
- Regulated environment experience (cGMP, OSHA, EPA); familiarity with GMP quality systems (change control, non-conformances, CAPA, qualification/validation).
- Experience with system modifications, new process introduction, and capital project oversight.
- Capital project understanding in GMP facility (procurement, construction, startup, validation).
- Safety requirements knowledge in GMP biopharmaceutical settings.
- Independent/organized; strong communication, facilitation, teamwork; leadership and technical writing/presentation.
- Flexibility for 24/7 operations; occasional after-hours coverage; travel ability.
What You Can Expect Of Us
- Competitive and comprehensive Total Rewards Plans (in addition to base salary).
Application Instructions
- Apply now via careers.amgen.com.
What You Will Do
- Partner with corporate engineering to design, build, commission, and qualify new equipment and systems for drug substance production; develop domain expertise to support operations upon start-up.
- Support commissioning/qualification of manufacturing systems aligned with GMP requirements; interact with regulatory inspectors.
- Ensure safe installation/operation and compliance with environmental health/safety rules and regulations.
- Support system commissioning/qualification to meet manufacturing requirements and GMP.
- As a manufacturing systems owner, communicate and demonstrate regulatory compliance.
- Support new product/technology introductions via engineering assessments, equipment modifications, and engineering runs.
Site Operations
- Provide system support for biopharmaceutical process equipment; identify and implement engineering improvements/upgrades.
- Develop business cases; translate design requirements into equipment/system design, specifications, and support construction, startup, and validation.
- Develop maintenance programs, ensure spare parts availability, and coordinate maintenance.
- Identify performance risks and implement risk reduction strategies.
- Provide problem-solving support to reduce downtime; support technical root cause analysis and corrective/preventive actions.
- Provide rotational on-call/shift support for 24x7 reliability.
- On-site and up to 10% domestic/international travel.
Basic Qualifications
- Master’s degree
OR Bachelor’s degree + 2 years engineering experience
OR Associate’s degree + 6 years engineering experience
OR High school diploma/GED + 8 years engineering experience
Preferred Qualifications / Skills
- BS Chemical/Mechanical Engineering (or similar).
- 3+ years relevant experience; 2+ years in biopharmaceutical operations/manufacturing.
- Direct GMP biopharmaceutical facility equipment/system design & troubleshooting; experience with Solution Prep/Upstream/Downstream purification equipment (e.g., weigh & dispense, solution prep vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, UFDF skids) and support equipment (autoclaves, CIP, washers, clean steam, water for injection, etc.).
- Data-driven problem solving (Data Analytics, RCA, SPC, Six Sigma, Predictive Maintenance).
- Regulated environment experience (cGMP, OSHA, EPA); familiarity with GMP quality systems (change control, non-conformances, CAPA, qualification/validation).
- Experience with system modifications, new process introduction, and capital project oversight.
- Capital project understanding in GMP facility (procurement, construction, startup, validation).
- Safety requirements knowledge in GMP biopharmaceutical settings.
- Independent/organized; strong communication, facilitation, teamwork; leadership and technical writing/presentation.
- Flexibility for 24/7 operations; occasional after-hours coverage; travel ability.
What You Can Expect Of Us
- Competitive and comprehensive Total Rewards Plans (in addition to base salary).
Application Instructions
- Apply now via careers.amgen.com.