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&ID walkdowns, 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
Equipment & Process Experience
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&ID walkdowns
- Mechanical completion verification
- FAT/SAT participation
- 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
Preferred Qualifications
- Experience supporting large-scale biologics or mAbs manufacturing facilities
- Navisworks or other 3D model review experience
- Experience developing or supporting LOTO procedures
- Experience with major upstream equipment OEMs
Additional Information
- 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
Upstream Process Engineer in Raleigh at Technical Source
This position is listed as contract and onsite. It was posted 5 days ago.