Senior CQV Engineer

PSC Biotech • Holly Springs, NC

21h • Onsite

About The Position

We are hiring a motivated Senior CQV Engineer to join our team! The Senior CQV Engineer will oversee commissioning, qualification, and validation (CQV) activities for a major biopharmaceutical manufacturing expansion project. This role provides senior‑level leadership for commissioning, qualification, and validation (CQV) activities across facilities, utilities, process equipment, and manufacturing systems, ensuring readiness for GMP operations and regulatory approval. The ideal candidate is a hands‑on CQV leader with experience delivering large‑scale capital projects, strong project‑management skills, and the ability to lead cross‑functional teams in fast‑paced, highly regulated environments.

This position requires travel and on -site presence at multiple sites/locations within the US.

Requirements

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related field).
• 10+ years of experience in commissioning, qualification, and validation within GMP biopharmaceutical environments.
• Proven experience supporting large manufacturing expansions or capital projects.
• Strong leadership, communication, and stakeholder‑management skills.
• Experience with risk‑based CQV approaches and regulatory inspections.
• Familiarity with KNEAT or other electronic validation tools.
• Willingness to travel extensively.
• Must be authorized to work in the U.S
• No C2C at this time.

Responsibilities

• Lead all CQV workstream activities across facilities, utilities, equipment, and manufacturing systems for a large‐scale biopharmaceutical expansion project.
• Develop, manage, and execute CQV strategy, schedules, deliverables, and resource plans in alignment with project objectives and regulatory expectations.
• Oversee commissioning and qualification of biopharmaceutical process equipment, including tanks/vessels, CIP skids, etc.
• Ensure CQV documentation and testing meet GMP, FDA, EMA, and global regulatory expectations.
• Partner with engineering, quality, operations, automation, and vendors to drive compliant, on‑time execution.
• Identify and mitigate technical, compliance, and schedule risks.
• Provide regular status updates and progress reporting to project leadership.
• Support electronic validation lifecycle management using KNEAT or similar systems.
• Travel and work on‑site at multiple U.S. project locations as required.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level