Job Description:Job Description:Job SummaryThe 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.
Key ResponsibilitiesValidation 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
QualificationsEducation- Bachelor's degree in Engineering, Life Sciences, or related scientific discipline required
- Master's degree (MS/MSc) preferred
Experience- 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
- Experience supporting regulatory inspections (FDA, EMA, or equivalent) preferred
- Capital project experience including equipment design, selection, and commissioning preferred
Skills & Competencies- 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
Working Conditions- 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
#LI-TH1
er will interface with our clients and be responsible for preparing and executing commissioning and qualification documents for a variety of utility, facility, and process equipment.
At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work-therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.
