Validation Engineer III

Barry-Wehmiller•Boston, MA

6h•Onsite

About The Position

The Validation Engineer III will serve as a key member of the validation team, providing expert-level support to ensure facility equipment, utilities, processes, instrumentation, and computerized systems are qualified and maintained in a validated state in compliance with applicable regulatory requirements. This role functions as a Validation Subject Matter Expert (SME) responsible for leading validation activities, authoring protocols and reports, and providing technical guidance to cross-functional teams. The Validation Engineer III will coordinate and execute qualification activities while collaborating with internal stakeholders and external vendors to support ongoing operations and capital projects.

Requirements

Bachelor's degree in Engineering, Life Sciences, or related scientific discipline required
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 expertise as a Subject Matter Expert (SME) in one or more validation disciplines
Experience with GMP utilities (WFI, purified water, clean steam, compressed gases, HVAC) and manufacturing equipment
Strong technical writing skills with ability to author clear, compliant documentation
Solid working knowledge of cGMP regulations, FDA guidance documents, and industry standards (ISPE, PDA, GAMP)
Understanding of GDP requirements 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 with minimal supervision while also functioning effectively in a team environment
Self-motivated with demonstrated initiative and problem-solving abilities
Proficiency in Microsoft Office Suite; experience with electronic validation systems a plus
On-site presence required; may involve work in manufacturing, laboratory, and utility areas
Ability to gown into cleanroom environments as required
Occasional flexibility in schedule and travel may be needed to support project timelines or production schedules

Nice To Haves

Master's degree (MS/MSc) preferred
Experience supporting regulatory inspections (FDA, EMA, or equivalent) preferred
Capital project experience including equipment design, selection, and commissioning preferred

Responsibilities

Validation Documentation & Execution Author, review, and approve validation protocols, reports, and associated 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
Project & Program Management 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
Compliance & Change Control 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
Technical Expertise Serve as Subject Matter Expert (SME) in one or more of the following disciplines: Process Mapping Quality Management (Quality Risk Assessments; Change Controls; Deviations; CAPA; Documentation) Equipment qualification (autoclaves, controlled temperature units, filling equipment) Cleaning validation Aseptic process simulation (media fills) Computer system validation (CSV) Process validation Utility qualification (WFI, purified water, clean steam, HVAC) Environmental monitoring systems Provide technical guidance and troubleshooting support for equipment and system failures Deliver training on validation program elements to junior validation personnel
Quality Systems Support Author and support equipment and process-related deviation investigations and CAPA activities
Perform and support risk assessments (FMEA, etc.) 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