DeltaV Validation Engineer - GMP/CSV, 21 CFR 11

Trinity Consultants - Advent Engineering; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

ADVENT Engineering is seeking a Validation Engineer to join a team of engineers focused on design, automation, commissioning, and startup of processes and facilities for pharmaceutical and biotech clients.

Ideal candidates have 4+ years in FDA-regulated environments, DeltaV expertise, and strong technical writing skills to develop URS/IQ/OQ/PQ and related documentation, ensuring compliance with GDP and quality standards.

Qualifications

• B.S./M.S. in engineering or a related discipline.
• 4+ years of experience in an FDA-regulated environment.
• 2+ years of DeltaV experience and ability to design protocols for DeltaV software customizations.
• Experience in Design Documentation (URS, FRS, DS, and other engineering specifications) and Validation (IQ/OQ/PQ/CSV).
• Strong knowledge of Computer Systems Validation lifecycle and documentation.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

Responsibilities

• Draft and implement Quality System documentation to establish good validation practices.
• Author URS, IQ, OQ and PQ protocols and execute them per GDP guidelines and internal quality standards.
• Design validation approaches, coordinate validation activities, analyze results, and draft validation reports.
• Perform Data Integrity Assessments and review systems against 21 CFR Part 11.
• Provide input on user and/or functional requirements and interface with Manufacturers to ensure requirements are met.
• Support non-engineering staff to enable technology transfer and continuous improvement.
• Execute assigned duties on time and proactively notify delays to the validation manager.
• Review DeltaV software and specifications to design test protocols.
• Comply with regulatory, corporate, and Quality System policies.

Skills

Strong communication

Interpersonal skills

Technical writing

Education

B.S./M.S. in Engineering

Tools

DeltaV

Microsoft Word

Excel

PowerPoint

Job description

ADVENT Engineering is seeking a Validation Engineer to join a team of engineers focused on design, automation, commissioning, and startup of processes and facilities for pharmaceutical and biotech clients.

Ideal candidates have 4+ years in FDA-regulated environments, DeltaV expertise, and strong technical writing skills to develop URS/IQ/OQ/PQ and related documentation, ensuring compliance with GDP and quality standards.