Senior Process Engineer

Amgen•Holly Springs, NC

About The Position

Join Amgen’s 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 lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Process Engineer What you will do 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 Upstream and Downstream Process engineering and plant equipment .

Requirements

High School Diploma / GED and 10 years of Engineering experience OR Associate’s Degree and 8 years of Engineering experience OR Bachelor’s Degree and 4 years of Engineering experience OR Master’s Degree and 2 years of Engineering experience OR Doctorate Degree

Nice To Haves

Bachelor ’ s degree in Chemical or Mechanical Engineering .
6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
D irect 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, vi ral f iltration 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 p roduction 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

Site design, construction, start-up, and operational readiness: S upport 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.
S upport 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 e nsure 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.
P erform engineering assessments for plant equipment operations , implementing equipment modifications, and supporting engineering runs in support of new product/technology introductions as .
Site O perations: Responsible system owner for 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 .
Provid e technical mastery and problem-solving leadership to proactively reduce production downtime. This includes leading technical root cause analysis and implementation of corrective/preventive action s for families of systems .
Lead new product/technology introductions by performing engineering assessments, equipment performance risk assessmen ts, identifying gaps and owning their remediation, implementing equipment modifications, and supporting engineering runs .
Provide rotational on-call support and ensure 24x7 day-to-day reliability of Upstream and Downstream systems for plant operations.
Up to 10% domestic/international travel .