Process Engineer Solution Prep, Upstream, and Downstream

ProcessEngineer-Solution PrepUpstream 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/safetypracticerulesand 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 assessmentsimplementing 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 improvementsidentification 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 PrepUpstream 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.

• 3yearsof 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-conformancescorrective 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 asto 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.

Apply now and make a lasting impact with the Amgen team!

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.