CQV Project Lead

About the role

We are seeking an experienced CQV Project Lead to lead and oversee Commissioning and Qualification (C&Q) activities for pharmaceutical manufacturing projects. The CQV Project Lead will be responsible for the successful mobilization and leadership of C&Q teams, management of project schedules and resource forecasts, and delivery of C&Q activities in accordance with GMP requirements and project objectives. The ideal candidate will possess strong technical and project management expertise within pharmaceutical API manufacturing and/or peptide purification facilities and have a proven track record of delivering complex C&Q programs from planning through project completion. This is a full role based in Huntsville, AL, with an anticipated start of late October.

Responsibilities

• Lead and manage C&Q projects across the full project lifecycle, ensuring alignment with scope, schedule, budget, and quality objectives
• Ensure successful mobilization, onboarding, and deployment of C&Q personnel to support project execution
• Develop and maintain project schedules, resource forecasts, staffing plans, and workload projections
• Provide oversight and leadership for all commissioning, qualification, and validation activities, including planning, execution, documentation, and closeout
• Coordinate and manage C&Q deliverables, including commissioning protocols, IQ/OQ/PQ execution, reports, and turnover packages
• Collaborate with Engineering, Quality Assurance, Operations, Manufacturing, and external stakeholders to ensure project success
• Track project progress, identify risks and issues, and implement mitigation plans to maintain project timelines
• Manage vendors, contractors, and consulting partners supporting C&Q execution
• Ensure all CQV activities are performed in compliance with GMP, FDA, EMA, and applicable regulatory requirements
• Provide regular project updates, resource reports, and status communications to clients and senior leadership
• Drive continuous improvement initiatives and promote best practices in C&Q project execution

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
• 8+ years of experience in CQV, Validation, Engineering, or Technical Project Management within the pharmaceutical, biotechnology, or life sciences industry
• Demonstrated experience managing C&Q teams and overseeing large-scale commissioning, qualification, and validation programs
• Experience with pharmaceutical API manufacturing facilities and/or peptide purification operations is required
• Proven ability to develop and manage project schedules, resource forecasts, staffing plans, and project budgets
• Strong knowledge of CQV lifecycle activities, including commissioning, FAT/SAT, IQ, OQ, PQ, and validation documentation
• Experience applying risk-based CQV methodologies and industry best practices
• Thorough understanding of GMP, FDA, EMA, ICH, and other applicable regulatory requirements
• Excellent leadership, communication, stakeholder management, and problem-solving skills
• Experience managing multiple vendors, contractors, and cross-functional project teams
• Proficiency with project management and scheduling tools such as Microsoft Project, Smartsheet, Primavera P6, or equivalent

Benefits

• Medical, Dental, and Vision – PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts