Process Validation Engineer II — GMP Biotech

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

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.