Sr. Engineer, ARI Engineering Projects
Amgen
4 days ago
On-site
West Greenwich, RI
Operations
Sr Engineer, ARI Engineering Projects
What You Will Do
Provide technical engineering support for commercial biologics manufacturing operations, focused on upstream/downstream process systems and equipment. Serve as technical lead interfacing with A/E firms for equipment/process design, operational readiness, troubleshooting, capital project execution, and commissioning & qualification (C&Q), ensuring safe, compliant, and reliable GMP operations.
Responsibilities
- Provide technical expertise for upstream/downstream equipment integration, including bioreactors/cell culture, centrifugation, chromatography skids, UFDF, buffer/media prep, CIP/SIP, and single-use technologies.
- Lead troubleshooting and technical investigations for equipment, automation interactions, and operational performance.
- Support design, construction, startup, commissioning, and qualification of manufacturing equipment and facility modifications.
- Review/approve deliverables (e.g., P&IDs, equipment specifications, functional requirements, flow paths, design reviews, FAT/SAT protocols, automation specs, turnover documentation).
- Support utility tie-ins, operational readiness, New Product Introductions, and hyper care after startup.
- Lead/support C&Q for GMP process systems and ensure compliance with GMP, safety, site procedures, and regulatory expectations (IQ/OQ/PQ, test runs, risk assessments, change controls, deviations, CAPAs).
- Drive continuous improvement: reliability, throughput, robustness, efficiency; lead RCA and CAPA implementation; support predictive maintenance and performance monitoring.
- Collaborate with Manufacturing, Process Development, Quality, Maintenance, Automation, EHSS, and Global Engineering; mentor junior engineers and promote safety/accountability.
Basic Qualifications
- High school/GED + 10 years engineering OR Associate’s + 8 years OR Bachelor’s + 4 years OR Master’s + 2 years OR Doctorate.
Preferred Qualifications
- Degree in Chemical/Mechanical/Bioprocess Engineering or related field.
- Experience in GMP biopharmaceutical manufacturing; knowledge of upstream/downstream equipment (bioreactors, centrifuges, chromatography, UFDF skids, single-use, CIP/SIP).
- Experience with C&Q, capital project execution, lifecycle management projects, process troubleshooting, operational readiness, and manufacturing support.
- Knowledge of GMP quality systems (change controls, deviations, CAPAs, risk assessments, validation documentation).
- Experience with DeltaV/process automation (preferred); strong problem-solving and communication; ability to lead cross-functional initiatives.
Application Instructions
Apply at careers.amgen.com (no application deadline; applications accepted until sufficient candidates are received or selected).
What You Will Do
Provide technical engineering support for commercial biologics manufacturing operations, focused on upstream/downstream process systems and equipment. Serve as technical lead interfacing with A/E firms for equipment/process design, operational readiness, troubleshooting, capital project execution, and commissioning & qualification (C&Q), ensuring safe, compliant, and reliable GMP operations.
Responsibilities
- Provide technical expertise for upstream/downstream equipment integration, including bioreactors/cell culture, centrifugation, chromatography skids, UFDF, buffer/media prep, CIP/SIP, and single-use technologies.
- Lead troubleshooting and technical investigations for equipment, automation interactions, and operational performance.
- Support design, construction, startup, commissioning, and qualification of manufacturing equipment and facility modifications.
- Review/approve deliverables (e.g., P&IDs, equipment specifications, functional requirements, flow paths, design reviews, FAT/SAT protocols, automation specs, turnover documentation).
- Support utility tie-ins, operational readiness, New Product Introductions, and hyper care after startup.
- Lead/support C&Q for GMP process systems and ensure compliance with GMP, safety, site procedures, and regulatory expectations (IQ/OQ/PQ, test runs, risk assessments, change controls, deviations, CAPAs).
- Drive continuous improvement: reliability, throughput, robustness, efficiency; lead RCA and CAPA implementation; support predictive maintenance and performance monitoring.
- Collaborate with Manufacturing, Process Development, Quality, Maintenance, Automation, EHSS, and Global Engineering; mentor junior engineers and promote safety/accountability.
Basic Qualifications
- High school/GED + 10 years engineering OR Associate’s + 8 years OR Bachelor’s + 4 years OR Master’s + 2 years OR Doctorate.
Preferred Qualifications
- Degree in Chemical/Mechanical/Bioprocess Engineering or related field.
- Experience in GMP biopharmaceutical manufacturing; knowledge of upstream/downstream equipment (bioreactors, centrifuges, chromatography, UFDF skids, single-use, CIP/SIP).
- Experience with C&Q, capital project execution, lifecycle management projects, process troubleshooting, operational readiness, and manufacturing support.
- Knowledge of GMP quality systems (change controls, deviations, CAPAs, risk assessments, validation documentation).
- Experience with DeltaV/process automation (preferred); strong problem-solving and communication; ability to lead cross-functional initiatives.
Application Instructions
Apply at careers.amgen.com (no application deadline; applications accepted until sufficient candidates are received or selected).