CSV Validation Engineer for Pharma & Biotech

Trinity Consultants - Advent Engineering; Massachusetts; On-site; USD 90,000 - 120,000; Full time

Job summary

Trinity Consultants - Advent Engineering seeks a skilled Validation Engineer to join the ADVENT team. The role focuses on quality system documentation, design validation, and 21 CFR Part 11 compliance within FDA-regulated projects for pharmaceutical facilities.

You will draft URS, IQ, OQ, PQ protocols, coordinate validation activities, review data integrity, and support tech transfer with R&D and manufacturing. DeltaV software experience and strong technical writing are essential for success.

Qualifications

• Must have strong knowledge of Quality System documentation and validation practices.
• Experience authoring URS, IQ, OQ and PQ protocols for GMP/GLP projects.
• Solid understanding of FDA regulatory requirements and 21 CFR Part 11.
• Excellent technical writing and documentation skills.

Responsibilities

• Draft and implement Quality System documentation designed to establish good validation practices.
• Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.
• Design validation approaches, supported by statistical analyses, coordinate all validation activities and draft results reports.
• Perform Data Integrity Assessments and review systems against 21 CFR Part 11.
• Provide input on user/functional requirements and interface with manufacturers for validation.
• Support non-engineering staff to ensure technology transfer and continuous improvement.
• Review DeltaV software and design test protocols; ensure regulatory compliance.

Skills

Quality System documentation

URS/IQ/OQ/PQ authoring

FDA regulatory compliance

Technical writing/presentation

Education

B.S./M.S. in engineering

Tools

DeltaV

MS Office

Job description

Trinity Consultants - Advent Engineering seeks a skilled Validation Engineer to join the ADVENT team. The role focuses on quality system documentation, design validation, and 21 CFR Part 11 compliance within FDA-regulated projects for pharmaceutical facilities.

You will draft URS, IQ, OQ, PQ protocols, coordinate validation activities, review data integrity, and support tech transfer with R&D and manufacturing. DeltaV software experience and strong technical writing are essential for success.