Position Details

Type Not Specified

Experience mid

Exp. Years 4+ years

Education Bachelor's degree in Engineering or related field; equivalent education and related training

Category Engineering (Non-Software)

About this role

Senior Drug Substance Process Engineer role focused on planning, design, construction, operations and maintenance for Amgen's DS facility with an emphasis on capital projects and DS process systems.

Key Responsibilities

Planning and standards development
Design and optimize systems
Construction support
Commissioning and qualification
Operations and maintenance guidance

Technical Overview

Involves design and commissioning/qualification of process equipment, adherence to cGMP and regulatory standards, and global network collaboration for asset lifecycle management.

Ideal Candidate

The ideal candidate is an experienced pharmaceutical process engineer with 4+ years in process systems design and capital projects, capable of leading commissioning and qualification efforts, with strong regulatory knowledge (cGMP) and travel availability.

Must-Have Skills

Bachelor's degree in Engineering or related field4+ years of engineering experienceAbility to travel up to 30%Strong communication skillsAnalytical problem solving

Nice-to-Have Skills

Master's degree in Engineering or BusinessBanking industry knowledgeKnowledge of cGMP and regulatory complianceExperience with enterprise project management tools

Tools & Platforms

CIP/SIPHVACRegulatory complianceCapital projectsEngineering design

Required Skills

Process engineeringcapital projectscommissioning and qualificationCIP/SIPHVACutilitiesregulatory compliancecGMPdesign standardsequipment integration

Hard Skills

Process engineeringCapital project managementCommissioning and qualification (C&Q)HVACCIP/SIPUtilitiesRegulatory compliance (cGMP)Design standardsEquipment integrationProject lifecycle management

Soft Skills

LeadershipCommunicationCross-functional collaborationAnalytical thinkingProblem solving

Certifications

Preferred

Professional Engineer (PE) (preferred)

Industry & Role

Industry Healthcare & Medical

Job Function Lead process equipment design and commissioning for DS facility expansion

Role Subtype Engineering (Non-Software)

Keywords for Your Resume

drug substance process engineeringprocess systems engineeringcapital projectscommissioning and qualificationcip siphvacutilitiescgmpboiler and pressure vessel codesregulatory complianceproject managementdesign standardsequipment integrationteam leadershiptravel up to 30%process engineeringCIP/SIPHVACcGMP

Deal Breakers

No engineering degree, Less than 4 years engineering experience, unwillingness to travel up to 30%

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Senior Engineer - Drug Substance Process Engineering

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