Senior Process Engineer - Solution Prep, Upstream, and Downstream

Responsibilities

• 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 teams to ensure systems are installed and operated safely and comply with pertinent environmental health/safety practices, rules, and regulations as well as Amgen global engineering requirements. Ensure systems are installed per the design requirements.
• Execute and guide the commissioning and validation of systems to ensure their operational capability aligns with manufacturing requirements and GMP regulation and on-time project delivery. Support execution of engineering and performance qualification runs while providing hyper-care 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.
• 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.

Requirements

• Doctorate degree
• OR Masters degree and 2 years of Engineering experience
• OR Bachelors degree and 4 years of Engineering experience
• OR Associates degree and 8 years of Engineering experience
• OR High school diploma / GED and 10 years of Engineering experience
• 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, including 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, 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