Process Engineer - Solution Prep, Upstream, and Downstream

BioSpace; Holly Springs (NC); On-site; USD 90,000 - 140,000; Full time

Job summary

Amgen is seeking a Process Engineer in North Carolina to join the Facilities & Engineering team. You will design, build, commission, and qualify drug substance production equipment and support start-up readiness.

The role requires GMP knowledge, experience with Upstream/Downstream purification, and the ability to analyze problems using data-driven methods. Travel up to 10% may be needed as part of 24/7 operations.

Qualifications

• Masters degree is required or a Bachelor’s degree with 2 years of engineering experience.
• Associates degree with 6 years of engineering experience.
• High school diploma / GED with 8 years of engineering experience.
• Experience with GMP Biopharmaceutical production equipment and systems.
• Data-driven problem solving (RCA, SPC, Six Sigma) and strong teamwork.

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Support commissioning and qualification in line with GMP and regulators.
• Ensure systems operate safely and comply with EH&S and GMP requirements.
• Interact with regulatory inspectors to demonstrate compliance of operating systems.
• Assist with new product/technology introductions and engineering runs.
• Provide 24/7 on-call support for solution prep, upstream, and downstream operations.

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.

ProcessEngineer-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 as well as developing domain expertise tosupport operations upon start-up.

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

• Support the commissioning and qualification ofmanufacturingsystems in alignment with GMP requirements and interact with regulatory inspectors.
• Ensuresystemsare installed andoperatesafelyandcomply withpertinent environmental health/safetypractice,rulesand regulations.
• Support commissioning and qualification of systemsto ensure their operational capabilityis alignedwithmanufacturing requirements andGMPregulations.
• Interact with regulatory inspectorsas a manufacturing systems owner to communicate anddemonstrateappropriate regulatorycomplianceofoperating systems.
• Assistwithnew product/technology introductions by performing engineering assessments,implementing equipment modifications, and supporting engineering runs.

Site Operations

• Provide systemsupportforbiopharmaceutical process equipment.Assistinidentifyingand implementing engineering-based improvements or upgrades to equipment or facility systems.
• Support the developmentofbusiness cases for improvements,identification ofdesign requirements, and translation ofthese requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation ofimprovements.
• Develop equipment maintenance programs, ensure the availability of spare parts, andcoordinatemaintenance activities to ensure systems are in proper working order.
• Providesystem guidance toidentifyperformance risks and implement risk reduction strategies.
• Provideproblem solving support to reduce production downtime. Thisincludessupporting technical root cause analysis and implementation of corrective/preventiveaction.
• Provide rotational on-call supportand/or shift supportbased on business needstoensure24x7 day-to-dayreliability ofSolution Prep,Upstream and Downstream systemsfor plant operations.
• On-site and up to10% domestic/international travel.

What We Expectofyou

We are all different, yet we all use our unique contributions to serve patients. The engineering professional weseekenjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications

Masters degree

OR

Bachelorsdegree and 2 years ofEngineeringexperience

OR

Associatesdegree and 6 years ofEngineeringexperience

OR

High school diploma / GED and 8 years ofEngineeringexperience

Preferred Qualifications

• Bachelors degree in Chemical or Mechanical Engineeringor similarengineerdiscipline.
• 3+years'of relevant work experience with2+ years' experience in Biopharmaceuticaloperations/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.
• Ability to analyze problems, develop and propose engineering solutions in a scientificmanner using data-driven techniques and analyses (e.g., Data Analytics, Root CauseAnalysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• 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
• Experience applying engineering principles to the design and implementation of systemmodifications, introduction of new processes, and the oversight of capital projects
• Understanding of capital projects in a GMP Biopharmaceutical Production facility includingprocurement, construction, startup, and validation
• Understanding ofsafety requirements working in a GMP Biopharmaceutical Productionfacility.
• Independent, ambitious, organized, able to multi-task in project environments, and skilled incommunication, facilitation, and teamwork
• Collaborativeteammateprepared to work in and embrace ateam basedenvironment thatrelies on communication for effective decision-making
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility asrequiredto support 24/7 operations, requiring occasionalafterhoursengineering coverage
• 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.