Validation Specialist

United Pharma Technologies Inc; Massachusetts; On-site; USD 90,000 - 120,000; Full time

Job summary

A leading pharmaceutical technology company is looking for a Senior Validation Engineer to lead validation activities for manufacturing processes and computerized systems in a regulated IVD/Medical Device environment. The role requires extensive validation experience, ensuring compliance with global regulatory standards. Responsibilities include executing validation activities, developing documentation, and collaborating with teams across QA, Manufacturing, R&D, QC, and IT for continuous improvement.

Qualifications

• 10+ years of validation experience in Medical Devices / IVD / Pharma.
• Strong hands-on experience in IQ/OQ/PQ, TMV, and CSV.

Responsibilities

• Execute and lead IQ/OQ/PQ, Test Method Validation (TMV), and CSV (GAMP 5).
• Develop validation plans, protocols, and reports.
• Perform risk-based validation (ISO 14971), CTQ alignment, and statistical analysis (MSA).
• Support change control, deviation investigations, and revalidation activities.
• Ensure compliance with ISO 13485, IVDR (EU 2017/746), FDA 21 CFR 820/11.
• Collaborate with QA, Manufacturing, R&D, QC, and IT teams.
• Support NPI, process transfers, and continuous improvement initiatives.

Skills

Validation lifecycle (process, equipment, methods, systems)

Statistical tools (MSA, capability analysis)

Strong technical writing and documentation skills

Experience in GxP and regulatory environments

Education

Bachelor’s or Master’s in Engineering or related field

Job description

Job Title: Senior Validation Engineer (IVD / Medical Devices)

About the Role

We are looking for a Senior Validation Engineer to lead validation activities for manufacturing processes, equipment, test methods, and computerized systems in a regulated IVD / Medical Device environment. This role ensures compliance with global regulatory standards and supports both new and legacy process validation.

Key Responsibilities

• Execute and lead IQ/OQ/PQ, Test Method Validation (TMV), and CSV (GAMP 5)
• Develop validation plans, protocols, and reports
• Perform risk-based validation (ISO 14971), CTQ alignment, and statistical analysis (MSA)
• Support change control, deviation investigations, and revalidation activities
• Ensure compliance with ISO 13485, IVDR (EU 2017/746), FDA 21 CFR 820/11
• Collaborate with QA, Manufacturing, R&D, QC, and IT teams
• Support NPI, process transfers, and continuous improvement initiatives

Qualifications

• Bachelor’s or Master’s in Engineering or related field
• 10+ years of validation experience in Medical Devices / IVD / Pharma
• Strong hands‑on experience in IQ/OQ/PQ, TMV, and CSV

Key Skills

• Validation lifecycle (process, equipment, methods, systems)
• Statistical tools (MSA, capability analysis)
• Strong technical writing and documentation skills
• Experience in GxP and regulatory environments