Process Engineer - Solution Prep, Upstream, and Downstream

Amgen • Holly Springs, NC

5d • Onsite

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is a leader in biotechnology, pioneering treatments for serious illnesses in Oncology, Inflammation, General Medicine, and Rare Disease. This role is part of Amgen's newest and most advanced drug substance manufacturing plant, the FleX batch facility, which combines disposable and traditional equipment with industry 4.0 capabilities and sustainability innovations. The facility aims to be carbon-neutral by 2027.

Requirements

• Master’s degree OR Bachelor’s degree and 2 years of Engineering experience OR Associate’s degree and 6 years of Engineering experience OR High school diploma / GED and 8 years of Engineering experience
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• 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
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and the oversight of capital projects
• Understanding of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and 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
• Collaborative teammate prepared to work in and embrace a team based environment that relies on communication for effective decision-making
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility as to support 24/7 operations, requiring occasional after hours engineering coverage
• Ability for domestic/international travel.

Nice To Haves

• Bachelor’s degree in Chemical or Mechanical Engineering or similar engineer discipline.
• 3 + years' of relevant work experience with 2 + 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.

Responsibilities

• Support the commissioning and qualification of manufacturing systems in alignment with GMP requirements and interact with regulatory inspectors.
• Ensure systems are installed and operate safely and comply with pertinent environmental health/safety practice, rules and regulations.
• Support commissioning and qualification of systems to ensure their operational capability is aligned with manufacturing requirements and GMP regulations.
• Interact with regulatory inspectors as a manufacturing systems owner to communicate and demonstrate appropriate regulatory compliance of operating systems.
• Assist with new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Provide system support for biopharmaceutical process equipment.
• Assist in identifying and implementing engineering-based improvements or upgrades to equipment or facility systems.
• Support the development of business cases for improvements, identification of design requirements, and translation of these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of improvements.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order.
• Provide system guidance to identify performance risks and implement risk reduction strategies.
• Provide problem-solving support to reduce production downtime, including supporting technical root cause analysis and implementation of corrective/preventive action.
• 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.

Benefits

• Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED