Single-Use Systems Validation Lead – Biotech GMP

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

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.