Single-Use Systems Validation Engineer

i-Pharm GxP; New Jersey; Hybrid; USD 90,000 - 130,000; Part time

Job summary

i-Pharm GxP is seeking a Senior Single-Use Systems Validation Engineer to lead qualification of SUS components across upstream and downstream processing in New Jersey.

Responsibilities include developing IQ/OQ/PQ protocols for bags, tubing, connectors and filters; coordinating extractables/leachables testing; reviewing validation documentation; and acting as SME during client audits and regulatory inspections.

Qualifications

• 5–8+ years in GMP biotech/pharma validation
• Proven experience qualifying single-use components
• Experience with extractables/leachables assessments
• Upstream and/or downstream biologics operations experience

Responsibilities

• Develop and execute IQ/OQ/PQ validation protocols for SUS components
• Lead extractables/leachables risk assessments and coordinate testing
• Evaluate vendor change notifications and assess impact on validation packages
• Support integrity testing strategies for SUS assemblies and ensure acceptance criteria
• Maintain the SUS validation master plan and component qualification matrix
• Troubleshoot deviations and drive root cause investigations
• Review and approve validation docs, changes, and deviations
• Act as SME during client audits and regulatory inspections

Skills

Validation engineering

Single-use systems

Regulatory compliance

QA documentation

Education

Bachelor's degree in Chemical/Biochemical Engineering, Biotechnology or related scientific discipline

Job description

Title: Single-Use Systems (SUS) Validation Engineer

Location: New Jersey, United States

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

Onsite Requirement: Hybrid

Overview

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.

Key Responsibilities

• 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

Required Experience

• 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

Preferred Experience

• 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