Single-Use Systems Validation Engineer

Title: Single-Use Systems (SUS) Validation Engineer

Location: New Jersey, United States

Contract: 12-month Contract (2-3+ year scope)

Onsite Requirement: Hybrid

We are supporting a biologics drug substance manufacturer expanding its single-use manufacturing platform in New Jersey, and are seeking an experienced Single-Use Systems Validation Engineer to lead qualification of single-use components and assemblies across upstream and downstream processing.

This role exists to ensure every single-use component entering the process train - bags, tubing, connectors, filters and sensors - is qualified for extractables/leachables, integrity and process fit, with documentation built to withstand regulatory scrutiny. You will work closely with Manufacturing, Quality and Supply Chain to keep validation pace aligned with an aggressive production schedule.

• Develop and execute validation protocols (IQ/OQ/PQ) for single-use systems including bioreactor bags, tubing assemblies, connectors, filters and bag-based hold systems
• Lead extractables and leachables (E&L) risk assessments and coordinate testing with internal labs or external CROs
• Evaluate vendor change notifications for single-use components and assess impact to existing validation packages
• Support integrity testing strategy (e.g. pressure decay, dye ingress) for single-use assemblies and ensure results meet acceptance criteria
• Maintain the single-use systems validation master plan and component qualification matrix
• Partner with Manufacturing and Process Engineering to troubleshoot single-use related deviations and drive root cause investigations
• Review and approve validation documentation, change controls and deviations tied to single-use equipment
• Act as SME for single-use systems during client audits and regulatory inspections

• 5–8+ years in validation engineering within a GMP biotech or pharmaceutical manufacturing environment, with direct single-use systems experience
• Demonstrable experience qualifying single-use components and managing extractables/leachables assessments
• Strong understanding of single-use platform suppliers and component change control processes
• Experience supporting upstream and/or downstream biologics manufacturing operations
• Bachelor's degree in Chemical/Biochemical Engineering, Biotechnology or related scientific discipline

• Experience supporting a new facility start-up or single-use platform conversion from stainless steel
• Familiarity with BPSA/BPOG guidance on single-use system qualification and extractables testing
• Experience managing vendor relationships and change notifications across multiple single-use suppliers
• Track record supporting FDA pre-approval or routine GMP inspections on single-use related topics
  
  Comfortable operating with autonomy and managing multiple component qualification timelines simultaneously