Senior Validation Engineer: cGMP/CSV SME

barrywehmiller; Boston (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Barry‑Wehmiller Design Group is seeking a Validation Engineer III to lead validation activities ensuring equipment, utilities, and systems stay compliant within a regulated environment. You will author protocols, manage qualification efforts, and guide cross-functional teams on cGMP standards.

The role requires SME-level expertise in validation disciplines, strong technical writing, and project management for equipment design, installation, and commissioning within manufacturing settings.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related scientific discipline required
• Master's degree (MS/MSc) preferred
• Minimum 5+ years of professional experience in validation, engineering, or operations within a regulated environment
• Minimum 4+ years of direct experience in a cGMP pharmaceutical, biotechnology, or medical device manufacturing environment
• Demonstrated SME in one or more validation disciplines
• Experience with GMP utilities and manufacturing equipment
• Experience supporting regulatory inspections preferred

Responsibilities

• Author, review, and approve validation protocols, reports, and documentation including acceptance criteria development
• Establish, revise, and maintain validation master plans, procedures, and lifecycle documentation for qualification of equipment, systems, and processes in accordance with cGMP requirements
• Execute and oversee IQ/OQ/PQ protocols for equipment, utilities, and systems
• Review and complete documentation in accordance with cGMP, ALCOA+ principles, and data integrity requirements
• Lead and manage validation‑related project activities including scheduling, resource coordination, protocol execution, and report review
• Manage external vendors and contractors performing qualification activities
• Serve as a key member of project teams for design, procurement, installation, and commissioning of new equipment and facility expansion projects
• Develop and maintain validation project timelines and deliverables
• Review proposed changes to validated systems and provide impact assessments
• Identify validation requirements necessary to maintain systems in a validated state following change implementation
• Manage periodic requalification activities to ensure equipment, utilities, and processes remain compliant
• Support equipment and building monitoring systems compliance and updates
• Provide technical guidance and troubleshooting support for equipment and system failures
• Deliver training on validation program elements to junior validation personnel
• Author and support equipment and process-related deviation investigations and CAPA activities
• Perform and support risk assessments and data integrity assessments
• Support internal audits and regulatory agency inspections
• Ensure all work is performed in accordance with SOPs, cGMPs, quality standards, and safety procedures
• Strong technical writing skills with ability to author clear, compliant documentation
• Solid working knowledge of cGMP regulations, FDA guidance documents, and industry standards
• Understanding of GDP and ALCOA+ data integrity principles
• Excellent communication and interpersonal skills with ability to interface across all organizational levels
• Strong project management and organizational skills
• Ability to work independently while also functioning in a team
• Self‑motivated with initiative and problem‑solving abilities
• Proficiency in Microsoft Office; experience with electronic validation systems a plus

Skills

Technical writing

Project management

Communication

Problem-solving

Independent work

Team collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Master's degree preferred

Tools

Microsoft Office

Electronic validation systems

GAMP guidance

Job description

Barry‑Wehmiller Design Group is seeking a Validation Engineer III to lead validation activities ensuring equipment, utilities, and systems stay compliant within a regulated environment. You will author protocols, manage qualification efforts, and guide cross-functional teams on cGMP standards.

The role requires SME-level expertise in validation disciplines, strong technical writing, and project management for equipment design, installation, and commissioning within manufacturing settings.