Impactful Process Validation Engineer II (GMP Biotech)

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

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.