Senior Manager Process Engineering - Bulk Drug Substance - Downstream
Amgen
July 01, 2026
On-site
Holly Springs, NC
Operations
Senior Manager Process Engineering (Downstream)
What You Will Do
- Oversee the engineering team, lead technical projects, and drive innovation in product design and manufacturing processes.
- Solve complex engineering problems, optimize processes, and align engineering efforts with strategic objectives; provide leadership for 24/7 manufacturing and facility operations.
- Partner to design, build, commission, and qualify new equipment and systems needed for drug substance production; develop domain expertise to support operations at start-up.
Key Responsibilities
- Execute and guide commissioning/qualification of process equipment in alignment with GMP; support safe installation and on-time delivery.
- Ensure systems operate safely and comply with environmental health/safety rules and regulations.
- Perform engineering assessments; implement equipment modifications; support new product/technology introductions.
- Provide system ownership for downstream purification (chromatography/viral filtration skids, UFDF) and CIP/SIP skids.
- Lead process engineering professionals; main point of contact for process/equipment engineering.
- Collaborate with Manufacturing, Quality, Process Development, Maintenance, and partners; work with OEMs and service providers.
- Lead improvements/upgrades; develop business cases and translate requirements into specifications, construction, startup, and validation.
- Develop maintenance programs, ensure spare parts availability, coordinate maintenance activities.
- Ensure plant readiness and quality/regulatory compliance for audits; manage performance risks and troubleshoot process/system issues.
- Lead budgeting for process engineering; forecast costs and manage expenditures.
What We Expect of You
Basic Qualifications:
- High school/GED + 12 yrs engineering OR Associate’s + 10 yrs OR Bachelor’s + 8 yrs OR Master’s + 6 yrs OR Doctorate + 2 yrs.
- Minimum 2 years directly managing people and/or leading teams/projects/programs/resources.
Preferred Qualifications
- Bachelor’s in Chemical/Mechanical Engineering or related field; 8+ yrs relevant work with 5+ yrs in biopharmaceutical operations/manufacturing focused on process/plant engineering.
- Downstream purification and CIP/SIP experience; Tech Transfer, Process Design, Commissioning & Qualification.
- Regulated environment experience (cGMP/OSHA/EPA), working with regulatory agencies; GMP systems (change control, deviations, CAPA, qualification/validation).
- Knowledge of biopharmaceutical manufacturing equipment; strong leadership, technical writing, communication/presentation; analytical problem-solving; flexibility for 24/7 operations.
Benefits
- Base salary plus competitive and comprehensive Total Rewards Plans (aligned with local industry standards).
Application Instructions
- Apply now; careers.amgen.com.
What You Will Do
- Oversee the engineering team, lead technical projects, and drive innovation in product design and manufacturing processes.
- Solve complex engineering problems, optimize processes, and align engineering efforts with strategic objectives; provide leadership for 24/7 manufacturing and facility operations.
- Partner to design, build, commission, and qualify new equipment and systems needed for drug substance production; develop domain expertise to support operations at start-up.
Key Responsibilities
- Execute and guide commissioning/qualification of process equipment in alignment with GMP; support safe installation and on-time delivery.
- Ensure systems operate safely and comply with environmental health/safety rules and regulations.
- Perform engineering assessments; implement equipment modifications; support new product/technology introductions.
- Provide system ownership for downstream purification (chromatography/viral filtration skids, UFDF) and CIP/SIP skids.
- Lead process engineering professionals; main point of contact for process/equipment engineering.
- Collaborate with Manufacturing, Quality, Process Development, Maintenance, and partners; work with OEMs and service providers.
- Lead improvements/upgrades; develop business cases and translate requirements into specifications, construction, startup, and validation.
- Develop maintenance programs, ensure spare parts availability, coordinate maintenance activities.
- Ensure plant readiness and quality/regulatory compliance for audits; manage performance risks and troubleshoot process/system issues.
- Lead budgeting for process engineering; forecast costs and manage expenditures.
What We Expect of You
Basic Qualifications:
- High school/GED + 12 yrs engineering OR Associate’s + 10 yrs OR Bachelor’s + 8 yrs OR Master’s + 6 yrs OR Doctorate + 2 yrs.
- Minimum 2 years directly managing people and/or leading teams/projects/programs/resources.
Preferred Qualifications
- Bachelor’s in Chemical/Mechanical Engineering or related field; 8+ yrs relevant work with 5+ yrs in biopharmaceutical operations/manufacturing focused on process/plant engineering.
- Downstream purification and CIP/SIP experience; Tech Transfer, Process Design, Commissioning & Qualification.
- Regulated environment experience (cGMP/OSHA/EPA), working with regulatory agencies; GMP systems (change control, deviations, CAPA, qualification/validation).
- Knowledge of biopharmaceutical manufacturing equipment; strong leadership, technical writing, communication/presentation; analytical problem-solving; flexibility for 24/7 operations.
Benefits
- Base salary plus competitive and comprehensive Total Rewards Plans (aligned with local industry standards).
Application Instructions
- Apply now; careers.amgen.com.