Process Validation Engineer II (GMP Biotech)

EPM Scientific; Fargo (ND); On-site; USD 90,000 - 120,000; Full time

Job summary

EPM Scientific is partnering with a biotech/CDMO to hire a Process Validation Engineer II for our Technical Operations team in Fargo, ND. The role focuses on process characterization, qualification, and validation activities across drug substance and drug product processes, with relocation available and onsite work.

The engineer will lead validation efforts, perform statistical analysis, manage risk assessments, and contribute to continuous improvement while interfacing with Manufacturing, QA,

Qualifications

• BS or MS in Engineering or related technical discipline.
• Experience with GMP pharmaceutical/biologics manufacturing.
• Understanding FDA process validation guidance and lifecycle validation.

Responsibilities

• Lead and support process validation activities across the lifecycle: Process Design, Qualification, and Continued Verification.
• Design and execute characterization studies and validation protocols.
• Analyze process performance with statistical tools including DOE, control charts, and trend analysis.
• Conduct risk assessments using pFMEA, criticality assessments, and RCA methodologies.
• Author protocols, reports, investigations, and risk assessments; support audits and inspections.

Skills

Statistical analysis

Technical writing

Root cause analysis

CAPA

DOE and process stats

Education

BS or MS in Engineering

Tools

IQ/OQ/PQ

Job description

EPM Scientific is partnering with a biotech/CDMO to hire a Process Validation Engineer II for our Technical Operations team in Fargo, ND. The role focuses on process characterization, qualification, and validation activities across drug substance and drug product processes, with relocation available and onsite work.

The engineer will lead validation efforts, perform statistical analysis, manage risk assessments, and contribute to continuous improvement while interfacing with Manufacturing, QA,