Senior Upstream Process Engineer – Biologics GMP
Job in
Raleigh, Wake County, North Carolina, 27601, USA
Listed on 2026-07-01
Listing for:
Technical Source
Full Time
position Listed on 2026-07-01
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Process Engineer, Quality Engineering
Job Description & How to Apply Below
Technical Source is seeking experienced Upstream Process Equipment Engineers to support a large-scale biologics manufacturing expansion project in Holly Springs, NC. This role will support startup, commissioning, qualification, and operational readiness activities for upstream manufacturing systems within a GMP biologics environment.
Opportunities include both supporting existing manufacturing operations as well as expansion efforts tied to new large-scale manufacturing facilities.
This is a highly visible, hands‑on engineering role supporting critical biologics manufacturing operations from equipment turnover through commercial production.
Responsibilities- Serve as equipment owner/work package owner for upstream process equipment systems
- Support startup, commissioning, qualification, and operational readiness activities
- Perform P&, redlines, and mechanical completion verification
- Conduct and participate in FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing)
- Support CQV (Commissioning, Qualification, and Validation) activities
- Interface with vendors, contractors, and cross-functional project teams
- Review equipment submittals and piping specifications
- Provide troubleshooting support during engineering runs, PPQ (Process Performance Qualification), and commercial manufacturing campaigns
- Support campaign changeovers and operational readiness activities
- Participate in investigations, deviations, CAPA development, and change control activities
- Support risk assessments related to equipment and process changes
- Assist with LOTO (Lock Out Tag Out) identification and procedure support
- Participate in 3D model reviews using Navisworks or similar tools
Required Qualifications
- 5+ years of experience in biopharma or biologics process/equipment engineering
- Strong upstream process equipment experience within GMP manufacturing environments
- Experience owning equipment through startup, commissioning, CQV, and operational support
- Hands‑on field execution experience including:
- P&
- Mechanical completion verification
- Startup troubleshooting
- Experience with GMP investigations, deviations, CAPA, and change control
- Familiarity with risk assessments and equipment troubleshooting
- Strong knowledge of stainless steel process equipment and upstream operations
- Experience reviewing piping specifications and vendor documentation
- Experience supporting large-scale biologics or mAbs manufacturing facilities
- Navisworks or other 3D model review experience
- Experience with major upstream equipment OEMs
- Multi‑year project with long‑term stability through early 2028
- Opportunity to support a major biologics manufacturing expansion
- High‑impact engineering role with direct involvement in startup and commercial operations
- Competitive compensation available based on experience
- Some off‑hours or weekend support may be required during critical startup and CQV phases
Position Requirements
10+ Years
work experience
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