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Validation Engineer
Barry-Wehmiller. Author, review, and approve validation protocols, reports, acceptance criteria, validation master plans, procedures, and lifecycle documentation .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in validation protocols, cGMP compliance, and technical documentation within regulated environments. Proficient in managing validation projects, conducting risk assessments, and supporting regulatory inspections.
Highest-signal resume keywords
Validation Protocol DevelopmentCGMP ComplianceTechnical WritingSubject Matter Expert (SME)Risk Assessment
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Validation ProtocolsIQ/OQ/PQ ExecutionCGMP RegulationsData Integrity PrinciplesGMP UtilitiesValidation Master PlansDeviation InvestigationsCAPA ActivitiesCommissioning DocumentsProject Management
Soft Skills
LeadershipTrainingCommunication
Tools & Technologies
Microsoft Office Suite
Industry Keywords
FDA GuidanceALCOA+ PrinciplesISPE StandardsPDA StandardsGAMPLife SciencesPharmaceutical ManufacturingBiotechnologyMedical Device ManufacturingCleanroom Environments
About the role
Key responsibilities & impact- Author, review, and approve validation protocols, reports, acceptance criteria, validation master plans, procedures, and lifecycle documentation
- Establish and maintain qualification documentation in accordance with cGMP requirements
- Execute and oversee IQ/OQ/PQ protocols for equipment, utilities, and systems
- Review documentation according to cGMP, ALCOA+ principles, and data integrity requirements
- Lead validation-related projects, including scheduling, resource coordination, protocol execution, and report review
- Manage external vendors and contractors performing qualification activities
- Support design, procurement, installation, and commissioning of new equipment and facility expansion projects
- Develop and maintain validation project timelines and deliverables
- Review changes to validated systems and provide impact assessments
- Manage periodic requalification activities
- Support equipment and building monitoring systems compliance and updates
- Serve as a validation Subject Matter Expert and provide technical guidance and troubleshooting support
- Deliver training on validation program elements to junior validation personnel
- Author and support deviation investigations and CAPA activities
- Perform and support risk assessments and data integrity assessments
- Support internal audits and regulatory agency inspections
- Ensure work complies with SOPs, cGMPs, quality standards, and safety procedures
- Prepare and execute commissioning and qualification documents for utility, facility, and process equipment
Requirements
What you’ll need- 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
- Proficiency in Microsoft Office Suite
- Ability to gown into cleanroom environments as required
- On-site presence required
- Occasional flexibility in schedule and travel may be needed
- 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
Benefits
Comp & perks- Equal opportunity employer
- Reasonable accommodations during the interview process
- Pre-employment screening may include drug screening, reference checks, employment verifications, background screening and/or skills assessments