6500 - Lead CQV Engineer / Lead Validation Engineer

Senior Validation Engineer Responsibilities:

• Lead and execute validation and qualification activities for facilities, utilities, manufacturing equipment, laboratory systems, and/or computerized systems within GxP-regulated environments.
• Author, review, and approve validation deliverables, including URS, validation plans, risk assessments, protocols, test scripts, IQ/OQ/PQ documentation, deviations, traceability matrices, and validation/qualification summary reports.
• Plan, coordinate, and perform hands-on validation execution, including protocol execution, field verification, system walkdowns, functional testing, punch-list management, and acceptance testing.
• Serve as the validation technical lead for assigned projects, providing direction on validation strategy, scope, execution approach, documentation, and issue resolution.
• Coordinate with Engineering, Quality, Operations, Automation, IT, vendors, and other stakeholders to ensure validation activities, project milestones, and deliverables are completed on schedule.
• Review engineering and vendor documentation, including drawings, specifications, manuals, FAT/SAT documentation, and commissioning records, to establish validation requirements and execution strategies.
• Lead the identification, investigation, and resolution of deviations, discrepancies, change controls, and validation-related issues.
• Ensure validation documentation and execution activities comply with cGMP, GAMP 5, ASTM E2500, data integrity principles, Good Documentation Practices, and applicable regulatory requirements.
• Track validation deliverables, project schedules, risks, action items, and dependencies; proactively communicate status and escalate issues that may impact project timelines or compliance.
• Provide technical leadership, coaching, and mentoring to validation engineers and less experienced team members.
• Support development and continuous improvement of validation procedures, templates, standards, and best practices.
• Maintain strong working relationships with project stakeholders and provide clear communication regarding validation strategy, progress, risks, and execution status.

Job Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• 7+ years of validation/CQV experience within the pharmaceutical, biotechnology, medical device, or other regulated life sciences industries.
• Demonstrated hands-on experience with both authoring and execution of validation and qualification deliverables.
• Strong experience developing and executing IQ/OQ/PQ protocols, validation test scripts, commissioning documentation, and validation/qualification reports.
• Experience leading validation activities across one or more of the following: manufacturing equipment, process equipment, facilities, utilities, laboratory systems, automation, or computerized systems.
• Strong understanding of cGMP requirements, validation lifecycle principles, and risk-based validation approaches.
• Experience managing deviations, change controls, punch lists, action items, and resolution of validation issues.
• Demonstrated ability to independently manage multiple validation activities and deliverables while meeting project timelines.
• Project Lead or Project Management experience, including responsibility for coordinating project teams, schedules, deliverables, resources, risks, and stakeholder communication.
• Experience serving as a Validation Lead or CQV Lead on pharmaceutical or biotechnology capital projects.
• Experience managing validation workstreams from planning and requirements development through execution and final closeout.
• Strong knowledge of GAMP 5, ASTM E2500, risk-based qualification, data integrity/ALCOA+, and applicable FDA/EMA regulatory expectations.
• Experience coordinating and managing third-party vendors, contractors, and cross-functional project teams.
• Experience with project scheduling and tracking tools such as Microsoft Project, Smartsheet, Jira, or similar platforms.
• This role is hybrid - on-site presence between Wichita, KS and Boston, MA may be required.