Senior Upstream Process Engineer – Biologics GMP

Technical Source; Raleigh (NC); On-site; USD 110,000 - 170,000; Full time

Job description

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
• 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 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