Principal Process Engineer - Upstream/Downstream

Amgen•Holly Springs, NC

8d•Onsite

About The Position

Join Amgen’s Mission of Serving Patients. Amgen is a leader in biotech, 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 technologies with traditional equipment and integrates sustainability innovations to reduce carbon and waste. The Principal Process Engineer will join the Facilities & Engineering (F&E) group to partner with the corporate engineering team on the design, build, commission, and qualification of new equipment and systems for drug substance production. This role involves leading technical projects, driving innovation, solving complex engineering problems, optimizing processes, and ensuring alignment with strategic objectives. The position also provides leadership and guidance to the engineering team supporting 24/7 manufacturing and facility operations.

Requirements

Doctorate degree and 2 years of engineering experience OR Master’s degree and 4 years of engineering experience OR Bachelor’s degree and 6 years of engineering experience OR Associate’s degree and 10 years of engineering experience Or High school diploma / GED and 12 years of engineering experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Bachelor’s degree in Chemical or Mechanical Engineering or related technical field.
8 + years' of relevant work experience with 5 + years' experience in Biopharmaceutical operations/manufacturing environment focused on process and plant engineering function.
Demonstrated people and/or project management and leadership experience.
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems with direct experience with Upstream and Downstream purification equipment such as 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 designing and operating equipment used in biopharmaceutical manufacturing.
Experience with Tech Transfer, Process Design, and Commissioning & Qualification.
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and 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 to support 24/7 operations.
Ability for domestic/international travel.

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 the capital project team to ensure systems are installed and operating safely and comply with pertinent environmental health/safety practices, 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 regulations 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.
Provide system ownership for Upstream and/or Downstream Drug substance process equipment, areas, and systems providing end-to-end support for operations.
Serve as a main point of contact for Process and equipment engineering function.
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 mentorship and coaching to junior engineering peers when they encounter challenges and roadblocks, as appropriate.
Demonstrate knowledge and understanding of how building and process automation systems interact with and impact process equipment and be able to effectively communicate automation issues and needs to support groups and to management.
Effectively communicate the correct level of detail for process risks in a timely manner to support groups and leadership.
Provide rotational on-call support and ensure 24x7 day-to-day reliability of Upstream and Downstream systems for plant operations.