Senior Process Engineer - Solution Prep, Upstream, and Downstream

About the role

Join Amgens Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives. Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Responsibilities

• Partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production.
• Develop domain expertise and system ownership to support process operations, focusing on Solution Prep, Upstream, and Downstream Process engineering and plant equipment.
• 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.
• 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.
• 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 hyper-care support as needed.
• Be responsible for Solution Prep, Upstream, and Downstream Drug substance process equipment, areas, and systems, providing end-to-end support for operations.
• Collaborate with key customers and support groups (e.g., Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations.
• Lead identifying and implementing engineering-based improvements or upgrades to process equipment systems, including 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, including 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

Basic Qualifications:

• 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

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, including 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