Process Validation Engineer II

EPM Scientific; Fargo (ND); On-site; USD 85,000 - 120,000; Full time

Job summary

EPM Scientific seeks a Process Validation Engineer II to join our Technical Operations team in Fargo, ND. The role focuses on process characterization, qualification, and validation supporting GMP manufacturing of drug substances and products.

The ideal candidate holds a BS or MS in Engineering with experience in GMP pharma/biotech environments and a strong grasp of FDA validation guidance and lifecycle principles.

Qualifications

• Experience with GMP pharmaceutical/biotech manufacturing environments.
• Strong understanding of FDA process validation guidance and lifecycle validation principles.
• Experience with deviation investigations, root cause analysis, and CAPAs.
• Proficient in statistical methods and data analysis.

Responsibilities

• Lead and support process validation activities across the validation lifecycle.
• Design and execute process characterization studies and validation protocols.
• Analyze process performance using statistical tools and DOE.
• Conduct risk assessments and utilize pFMEA and criticality assessments.
• Author protocols, reports, investigations, and risk assessments.
• Support audits, regulatory inspections, and continuous improvement initiatives.

Skills

Statistical analysis

Process validation

cGMP knowledge

Deviation investigations

CAPA

Technical writing

Education

BS or MS in Engineering

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