Position Details

Type Not Specified

Experience senior

Exp. Years Not specified

Education Not specified

Category Engineering (Non-Software)

About this role

This Senior Process Engineer role supports drug substance production by partnering with the Facilities & Engineering (F&E) group to design, build, commission, and qualify new equipment and systems. The work spans site readiness, factory acceptance testing, and commissioning/validation aligned with GMP and EHS requirements.

Key Responsibilities

Support design and build of manufacturing equipment systems and documentation
Execute and guide factory acceptance testing (FAT) and resolve punch list items
Ensure safe, compliant installation aligned with EHS and Amgen global engineering requirements
Lead commissioning and validation to align operational capability with manufacturing requirements and GMP
Support site design, construction, start-up, and operational readiness

Technical Overview

The role focuses on upstream and downstream process engineering and plant equipment ownership for drug substance manufacturing. It includes supporting design reviews and documentation (including equipment sizing and piping and instrumentation diagrams), executing factory acceptance testing with protocol and punch list resolution, and leading commissioning and validation to ensure operational capability under GMP regulation.

Ideal Candidate

The ideal candidate is a senior Process Engineer who can partner with Facilities & Engineering (F&E) and corporate engineering to design, build, commission, and qualify new equipment and systems for drug substance production. They have strong upstream/downstream process engineering experience and can execute factory acceptance testing, commissioning, and validation aligned to GMP regulations and EHS requirements.

Must-Have Skills

Upstream and Downstream Process engineeringDesignbuildcommissionand qualify new equipment and systemsCommissioning and validationGMP regulation complianceFactory acceptance testingEnvironmental health/safety practice compliance

Required Skills

Upstream process engineeringDownstream process engineeringdesign and buildsite designsite constructionstart-upoperational readinessfactory acceptance testingFATprotocolspunch list itemscommissioningqualificationvalidationGMP regulationEHSequipment design and sizingarchitecture and electrical distributionpiping and instrumentation diagramscapital projects

Hard Skills

Upstream process engineeringDownstream process engineeringProcess operationsEquipment systems designDesign review processes and documentsEquipment design and sizingArchitecture and electrical distributionPiping and instrumentation diagramsFactory acceptance testingProtocol reviewPunch list items resolutionEnvironmental health/safety practiceEnvironmental health and safety (EHS)CommissioningValidationGMP regulationCapital projectsSite designSite constructionStart-upOperational readinessSystem installation per design requirementsTroubleshootingQualification of new equipment and systemsPlant equipment

Soft Skills

GuidanceCollaborationCommunicationCross-functional partnershipProblem-solving

Industry & Role

Industry Manufacturing

Job Function Own and deliver process engineering support for upstream/downstream drug substance equipment design, FAT, commissioning, and GMP-aligned validation

Role Subtype Process Engineer

Keywords for Your Resume

Senior Process EngineerFacilities & Engineering (F&E)Upstream process engineeringDownstream process engineeringprocess operationssite designsite constructionstart-upoperational readinessdesign and buildcommissioningqualificationvalidationGMP regulationfactory acceptance testingFATprotocolspunch listenvironmental health/safetyEHSenvironmental health/safety practicecapital project teamdesign review processes and documentsequipment design and sizingarchitecture and electrical distributionpiping and instrumentation diagramsoperational capabilitycompliance

Deal Breakers

Must have experience commissioning and validating systems in a GMP environment, Must have experience with factory acceptance testing (protocol review and punch list resolution)

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