Barry-Wehmiller · 4 hours ago
Validation Engineer III
Boston, MA
Full-time
Onsite
Senior Level
5+ years expBarry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology. The Validation Engineer III will provide expert-level support to ensure compliance of facility equipment and systems, leading validation activities and collaborating with internal and external teams.
Machinery
Responsibilities
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
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
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
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
Qualification
Required
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
Preferred
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
Company
Barry-Wehmiller
We’re Building A Better World. We’re more than just a successful capital equipment and engineering solutions firm.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Bob Chapman
CEO and Chairman
Doug McGraw
President & CEO, BW Flexible Systems
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