Senior Process Engineer - Solution Prep, Upstream, and Downstream

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 as.

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 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 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.

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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:

Doctorate degreeORMaster’sdegree and 2 years of Engineering experienceORBachelor’sdegree and 4years ofEngineeringexperienceOR Associate’sdegree and 8years ofEngineeringexperienceOR  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,and Downstreampurification 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 asto support 24/7 operations.

• Ability for domestic/international travel.