Senior Process Engineer - Solution Prep, Upstream, and Downstream Job at Amgen (Holly Springs)

Job Description

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.

Job Responsibility

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
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

Requirements

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

Nice to have

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

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Senior Process Engineer - Solution Prep, Upstream, and Downstream

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