Process Validation Engineer II

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

Process Validation Engineer II

Fargo, ND (Relocation Available) | Onsite

I'm partnering with a rapidly growing biotech/CDMO organization supporting the development and commercialization of cutting-edge therapies and currently seeking a Process Validation Engineer II to join their Technical Operations team.

This individual will play a key role in process characterization, qualification, and validation activities supporting GMP manufacturing operations across drug substance and drug product processes.

Key Responsibilities

• Lead and support process validation activities across the validation lifecycle (Process Design, Process Qualification, and Continued Process Verification)
• Design and execute process characterization studies and validation protocols
• Analyze process performance using statistical tools including DOE, control charts, process capability analysis, and trend analysis
• Conduct risk assessments utilizing pFMEA, criticality assessments, and risk-ranking methodologies
• Partner cross-functionally with Manufacturing, MSAT, QA, QC, Regulatory Affairs, and Engineering
• Author technical documentation including protocols, reports, investigations, and risk assessments
• Support client audits, regulatory inspections, and continuous improvement initiatives

What We're Looking For

• BS or MS in Engineering or related technical discipline
• Experience supporting process validation within GMP pharmaceutical, biologics, biotechnology, or advanced therapy manufacturing environments
• Understanding of FDA process validation guidance, cGMP requirements, and lifecycle validation principles
• Experience with deviation investigations, root cause analysis, CAPAs, and technical writing
• Strong statistical and data analysis skills

Preferred Experience

• CDMO environment
• Sterile manufacturing or fill-finish operations
• Equipment qualification (IQ/OQ/PQ)
• Client-facing validation support