Senior Validation Engineer Responsibilities:

• Lead and support Commissioning & Qualification (C&Q/CQV) activities for GMP facilities, utilities, equipment, and manufacturing systems throughout the project lifecycle.
• Develop, review, and execute C&Q deliverables including URS, risk assessments, DQ, FAT/SAT, commissioning test plans, IQ/OQ/PQ protocols, traceability matrices, and qualification summary reports.
• Coordinate C&Q execution activities, including protocol scheduling, field execution, test evidence collection, punch-list management, discrepancy/deviation resolution, retesting, and final documentation closeout.
• Support development and implementation of risk-based qualification strategies in accordance with GMP requirements, ASTM E2500, GEP, and applicable site/client procedures.
• Author, review, and update C&Q procedures, protocols, work instructions, commissioning documents, test scripts, templates, and qualification reports in accordance with Good Documentation Practices.
• Manage C&Q documentation through electronic document management and digital qualification platforms, ensuring proper formatting, metadata, traceability, approvals, and document lifecycle control.
• Support digital C&Q execution and documentation, including configuration and use of Kneat or similar C&Q/validation platforms, electronic protocols, test evidence, workflows, and qualification records.
• Coordinate with Engineering, Automation, Quality, Operations, Maintenance, Facilities, IT, Subject Matter Experts, site teams, and external vendors to ensure C&Q activities are aligned with project schedules and operational requirements.
• Maintain C&Q project trackers covering protocol status, execution progress, open actions, punch-list items, deviations, documentation readiness, system turnover, and qualification closeout.
• Support facility and equipment turnover, commissioning completion, qualification readiness, and operational handoff to site teams.
• Provide clear status updates on C&Q progress, schedule, risks, issues, dependencies, and outstanding actions to project and site leadership.
• Support inspection and audit readiness by ensuring C&Q documentation is complete, traceable, technically justified, and compliant with applicable GMP requirements.
• Support multiple concurrent C&Q projects and priorities while maintaining quality, schedule, and documentation requirements across a global, cross-functional organization.

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or another industry-related technical discipline.
• 5+ years of experience in C&Q/CQV, commissioning, qualification, validation, engineering, or technical project execution within regulated pharmaceutical, biotech, or life sciences environments.
• Demonstrated hands-on experience with commissioning and qualification of GMP facilities, utilities, equipment, manufacturing systems, or laboratory systems.
• Strong working knowledge of C&Q methodologies and deliverables, including URS, DQ, FAT/SAT, commissioning, IQ/OQ/PQ, traceability, risk assessments, deviations, and qualification summary reports.
• Working knowledge of GMP, GEP, ASTM E2500, risk-based qualification, and Good Documentation Practices.
• Kneat Power User Level 1 (or higher) certification highly preferred, with hands-on experience using Kneat or similar digital C&Q/validation platforms.
• Experience authoring, reviewing, and executing C&Q protocols, test scripts, commissioning documents, qualification reports, SOPs, work instructions, and other controlled documentation.
• Experience coordinating field execution with Engineering, Quality, Operations, Automation, Maintenance, vendors, and other cross-functional stakeholders.
• Familiarity with punch-list management, discrepancy/deviation resolution, change control, turnover, system handoff, and C&Q closeout activities.
• Strong understanding of requirements traceability, test evidence, documentation workflows, and qualification lifecycle management.
• Experience with HP ALM/Quality Center, Jira, or other project/test-management platforms preferred.
• Experience with BMS, Documentum, Veeva Vault, or other electronic document management systems preferred.
• Experience supporting large-scale pharmaceutical/biotech capital projects, facility expansions, equipment installations, or multi-site C&Q programs preferred.
• Strong written and verbal communication, organizational, problem-solving, and stakeholder-management skills.
• Ability to manage multiple priorities and work independently within a global, cross-functional project environment
• This role is remote; limited travel to client sites may be requested with advance notice.