Senior Process Engineer

SeniorProcess 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 domainexpertiseand system ownershipto supportprocessoperations focusing onUpstream 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 engineeringduringsiteinstallationincluding reviewing protocolsandresolving punch list items.

• Work withcapitalproject teamto ensure systems are installed andoperatingsafelyandcomply withpertinent environmental health/safety practicerulesand 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 operationsimplementing equipment modifications and supporting engineering runsin support of new product/technology introductions as.

Site Operations:

• Responsible system ownerforUpstreamandDownstreamDrug 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 improvementsidentifyingdesign requirements and translating these requirements intoprocessequipment/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 assessmentsequipment performance risk assessmentsidentifyinggaps and owning their remediationimplementing equipment modifications and supporting engineering runs.

• Provide rotational on-call support and ensure24x7 day-to-dayreliability ofUpstream andDownstream systemsfor plant operations.

• Up to10% domestic/international travel.

What we expect of you

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:

• High School Diploma / GED and 10 years of Engineering experience OR

• Associates Degree and 8 years of Engineering experience OR

• Bachelors Degree and 4 years of Engineering experience OR

• Masters Degree and 2 years of Engineering experience OR

• Doctorate Degree

Preferred Qualifications:

• Bachelors degree in Chemical or Mechanical Engineering.

• 6yearsof 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 withUpstream andDownstreampurification equipment suchascell culture reactors centrifugation chromatographyviralfiltration skidsandUFDFskidsas 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-conformancescorrective 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 asto support 24/7 operations.

• Ability for domestic/international travel.