Lead CQV Engineer

Job Summary

We are seeking a Lead CQV / Lead Validation Engineer to lead validation and qualification activities for pharmaceutical/biotech projects in a GxP-regulated environment. The ideal candidate will have strong hands-on CQV experience along with the ability to lead validation workstreams, coordinate cross-functional teams, and manage project deliverables from planning through closeout.

Key Responsibilities

• Lead and execute CQV/validation activities for facilities, utilities, manufacturing equipment, laboratory systems, and/or computerized systems.
• Develop, review, and approve URS, validation plans, risk assessments, IQ/OQ/PQ protocols, test scripts, traceability matrices, deviations, and final reports.
• Lead hands-on protocol execution, system walkdowns, functional testing, SAT/FAT activities, and punch-list resolution.
• Develop validation strategies and provide technical leadership for assigned projects.
• Coordinate with Engineering, Quality, Operations, Automation, IT, vendors, and contractors to meet project timelines.
• Manage deviations, change controls, validation issues, risks, action items, and project dependencies.
• Ensure compliance with cGMP, GAMP 5, ASTM E2500, ALCOA+/Data Integrity, and FDA/EMA requirements.
• Track project schedules, deliverables, and milestones while communicating status and risks to stakeholders.
• Provide technical guidance and mentoring to junior validation engineers.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field.
• 7+ years of CQV/Validation experience in pharmaceutical, biotechnology, medical device, or other regulated life sciences environments.
• Strong hands-on experience with IQ/OQ/PQ, commissioning, qualification, and validation documentation/execution.
• Experience leading validation activities for manufacturing equipment, facilities, utilities, laboratory systems, automation, or computerized systems.
• Strong knowledge of GAMP 5, ASTM E2500, risk-based validation, ALCOA+, and GxP requirements.
• Proven experience leading validation workstreams and coordinating cross-functional teams and vendors.
• Experience with project planning/scheduling tools such as Microsoft Project, Smartsheet, Jira, or similar.
• Strong communication, leadership, problem-solving, and project management skills.