ProcessEngineer - CIP/ SIP/ Autoclave

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.

• Demonstrate technical expertise and provide lifecycle support for CIP skid systems, SIP circuits, autoclaves, transfer panels, process tanks, valves, instrumentation, and associated automation platforms. The role will support commissioning, qualification, startup readiness, routine manufacturing operations, troubleshooting, and continuous improvement initiatives with a focus on CIP, SIP and autoclave systems.
• Ensuresystemsare installed andoperatesafelyandcomply withpertinent environmental health/safetypractice,rulesand regulations.
• 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 6specifically CIP/SIP and/or autoclave systems.Assistinidentifyingand implementing engineering-based improvements or upgrades to equipment or facility systems.
• Experience with CIP circuit design/validation and SIP
• 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.

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:

Masterdegree
OR
Bachelordegree and 2 years ofEngineeringexperience
OR
Associatedegree 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.

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, we9ll 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.

Salary Range