Process Validation Engineer II

United Pharma; North Dakota; On-site; USD 90,000 - 120,000; Full time

Job summary

United Pharma is seeking a Process Validation Engineer II to join its Technical Operations team in advancing GMP manufacturing for drug substance and drug product processes.

The role focuses on process characterization, qualification, and continued verification across the validation lifecycle, using statistical tools and quality systems to ensure product quality and regulatory compliance.

Qualifications

• Strong statistical and data analysis skills.
• Experience with deviation investigations, root cause analysis, CAPAs, and technical writing.
• Understanding of FDA process validation guidance and cGMP requirements.

Responsibilities

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

Skills

Statistical analysis

Technical writing

GMP knowledge

Education

B.S./M.S. in Engineering

Job description

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:

• Sterile manufacturing or fill-finish operations