Senior Process Engineer - Solution Prep, Upstream, and Downstream

Senior Process Engineer  - Solution Prep, Upstream, and Downstream 

What you will do 

In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will develop domain expertise and system ownership to support process operations, focusing on Solution Prep, Upstream, and Downstream Process engineering and plant equipment. 

Site design, construction, start-up, and operational readiness: 

• Support the design and build of manufacturing equipment systems by aligning design review processes and documents with site requirements, including equipment design and sizing, architecture and electrical distribution, and piping and instrumentation diagrams.  

• Support factory acceptance testing working in partnership with global engineering during site installation, including reviewing protocols and resolving punch list items.  

• Work with capital project team to ensure systems are installed and operating safely and comply with pertinent environmental health/safety practice, rules and regulations as well as Amgen global engineering requirements. Ensure that systems are installed per the design requirements.  

• Execute and guide the commissioning and validation of systems to ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery. Support execution of engineering and performance qualification runs while providing hypercare support as needed. 

• Perform engineering assessments for plant equipment operations, implementing equipment modifications, and supporting engineering runs in support of new product/technology introductions as required. 

Site Operations: 

• Responsible system owner for Solution Prep, Upstream, and Downstream Drug substance process equipment, areas, and systems providing end-to-end support for operations. 

• Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations. 

• Work with original equipment manufacturers for breakdown and planned maintenance of process equipment as applicable. 

• Lead identifying and implementing engineering-based improvements or upgrades to process equipment systems. This may include developing business cases for improvements, identifying design requirements, and translating these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment. 

• Develop master maintenance programs for equipment, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order. 

• Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the process equipment.  

• Provide technical mastery and problem-solving leadership to proactively reduce production downtime. This includes leading technical root cause analysis and implementation of corrective/preventive actions for families of systems. 

• Lead new product/technology introductions by performing engineering assessments, equipment performance risk assessments, identifying gaps and owning their remediation, implementing equipment modifications, and supporting engineering runs. 

• Provide rotational on-call support and/or shift support based on business needs to ensure 24x7 day-to-day reliability of Solution Prep, Upstream and Downstream systems for plant operations. 

• On-site and up to 10% domestic/international travel. 

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What we expect of you 

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications. 

Basic Qualifications: 

Doctorate degree  
OR 
Master’s degree and 2 years of Engineering experience 
OR 
Bachelor’s degree and 4 years of Engineering experience 
OR  
Associate’s degree and 8 years of Engineering experience 
OR   
High school diploma / GED and 10 years of Engineering experience 

Preferred Qualifications: 

• Degree in Chemical or Mechanical Engineering or similar engineering discipline. 

• 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment 

• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems with direct experience with Solution Prep, Upstream, and  Downstream purification equipment such as weigh and dispense equipment, solution preparation vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, and UFDF skids as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc. 

• Experience with Tech Transfer, Process Design, and Commissioning & Qualification. 

• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation 

• Understanding of safety requirements working in a GMP Biopharmaceutical production facility. 

• Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork. 

• Strong leadership, technical writing, and communication/presentation skills 

• Work schedule flexibility as required to support 24/7 operations. 

• Ability for domestic/international travel.