Senior Process Engineer - Solution Prep, Upstream, and Downstream

BioSpace; Holly Springs (NC); On-site; USD 120,000 - 175,000; Full time

Job summary

Amgen is seeking a Senior Process Engineer to join the Facilities & Engineering group, partnering with corporate engineering to design, build, commission, and qualify new equipment for drug substance production. You will develop domain expertise and system ownership to support operations in Solution Prep, Upstream, and Downstream.

The role requires collaboration with manufacturing, QA, and maintenance, ensuring readiness for audits and compliance with GMP requirements.

Qualifications

• Doctorate, MSc or Bachelors pathways with required years of engineering experience as stated in the job ad.
• Experience with GMP Biopharmaceutical Production facility equipment and systems.

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Support process operations focusing on Solution Prep, Upstream, and Downstream.
• Lead technical reviews, commissioning, qualification runs, and assist with validation activities.

Skills

Chemical Engineering

Biopharma ops

Process engineering

GMP compliance

Education

Doctorate degree

Masters degree with 2 years engineering experience

Bachelors degree with 4 years engineering experience

Associates degree with 8 years engineering experience

High school diploma / GED with 10 years engineering experience

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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.

SeniorProcessEngineer-Solution Prep,Upstream,andDownstream

What Youwill 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 domainexpertiseand system ownershipto supportprocessoperations, focusing onSolution Prep,Upstream,andDownstreamProcess engineering and plant equipment.

Site Design, Construction, Start-up, And Operational Readiness

• Support thedesign andbuildof manufacturingequipmentsystems byaligningdesign reviewprocessesand documentswith site requirements, including equipment design and sizing, architecture and electricaldistribution, and piping and instrumentation diagrams.
• Supportfactoryacceptancetestingworking in partnershipwith global engineeringduringsiteinstallation,including reviewing protocolsandresolving punch list items.
• Work withcapitalproject teamto ensure systems are installed andoperatingsafelyandcomply withpertinent environmental health/safety practice,rulesand regulationsas well as Amgen global engineering requirements.Ensurethat systems are installed per the designrequirements.
• Executeand guidethe commissioning and validationof systemsto ensure their operational capabilityis alignedwithmanufacturing requirements andGMPregulationand on-time project delivery.Supportexecution of engineering and performance qualification runswhile providinghypercaresupport as needed.
• Perform engineering assessmentsfor plant equipment operations,implementing equipment modifications, and supporting engineering runsin support of new product/technology introductions asrequired.

Site Operations

• Responsible system ownerforSolution Prep,Upstream,andDownstreamDrug substanceprocess equipment, areas, and systems providingend-to-endsupport 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 ofprocess equipmentas applicable.
• Leadidentifyingand implementing engineering-based improvements or upgrades toprocessequipmentsystems.This may include developing business cases for improvements,identifyingdesign requirements, and translating these requiredintoprocessequipment/system design, specifications, and supporting the construction, startup, and validation of equipment.
• Developmastermaintenance programsfor equipment, ensure the availability of spare parts, andcoordinate 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 theprocessequipment.
• Providetechnical masteryandproblem-solvingleadershiptoproactivelyreduce production downtime. Thisincludes leadingtechnical root cause analysis and implementation of corrective/preventiveactions for families of systems.
• Leadnew product/technology introductions by performing engineering assessments,equipment performance risk assessments,identifyinggaps 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 ensure24x7 day-to-dayreliability of Solution Prep, Upstream and Downstream systemsfor plant operations.
• On-site and up to10% domestic/international travel.

What We Expectofyou

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Basic Qualifications

Doctorate degree

OR

Mastersdegree and 2 years of Engineering experience

OR

Bachelorsdegree and4years ofEngineeringexperience

OR

Associatesdegree and8years ofEngineeringexperience

OR

High school diploma / GED and10years ofEngineeringexperience

Preferred Qualifications

• Degree in Chemical or Mechanical Engineeringor similar engineering discipline.
• 6+years'of relevant work experience with 5+ years' experience in Biopharmaceuticaloperations/manufacturing environment
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Productionfacility equipment/systemswith direct experience withSolution Prep,Upstream,andDownstreampurification equipment suchasweigh and dispense equipment, solution preparation vessels,cell culture reactors, centrifugation, chromatography,viralfiltration skids,andUFDFskidsas 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.) andfamiliarity with GMP quality systems/processes such as change control, non-conformances,corrective and preventative actions, and qualifications/validation
• Understanding ofsafety requirements working in a GMP Biopharmaceuticalproductionfacility.
• Independent, ambitious, organized, able to multi-task in project environments, and skilled incommunication, facilitation, and teamwork.
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility asrequiredto support 24/7 operations.
• Ability for domestic/international travel.

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.