Job Title: CQV Engineer

Location: Rocky Mount, NC - Onsite

Duration: 18+ Months on W2

We are seeking an experienced Commissioning, Qualification, and Validation (CQV) Engineers to lead complex projects involving filling lines, clean utility systems, and cleanroom modifications in our pharmaceutical manufacturing facilities. The ideal candidate will have a strong technical background in GMP environments and a proven track record of ensuring regulatory compliance and operational excellence.

Key Responsibilities

• Lead CQV activities for new and modified filling lines, including isolator systems
• Develop and execute IQ, OQ, and PQ protocols for filling equipment such as vial washers, depyrogenation tunnels, filling machines, and capping systems
• Perform risk assessments (e.g., FMEA) for filling line modifications and qualifications
• Troubleshoot and resolve technical issues during qualification activities Clean Utility Systems
• Manage CQV processes for clean utility systems, including purified water, Water for Injection (WFI), clean steam, and compressed air
• Develop validation strategies for utility distribution systems and storage tanks
• Collaborate with automation teams on DeltaV system integration and validation
• Ensure compliance with relevant pharmacopeia standards (e.g., USP, EP) for water systems
• Lead qualification efforts for cleanroom modifications and new installations
• Develop and execute protocols for HVAC system performance, including airflow studies and particle counting
• Coordinate with environmental monitoring teams to establish and validate monitoring protocols
• Ensure compliance with ISO 14644 standards and GMP Annex 1 requirements
• Generate comprehensive validation documentation, including protocols, test scripts, summary reports, and final qualification packages
• Maintain clear, detailed records of qualification activities and change control processes
• Prepare technical reports and presentations for management and regulatory bodies
• Collaborate with cross-functional teams, including engineering, manufacturing, quality assurance, and regulatory affairs
• Manage project timelines, resources, and budgets for CQV activities
• Participate in FAT/SAT activities at equipment vendor sites and on-site

Qualifications and Skills

• Bachelor's degree in Engineering, Life Sciences, or related field; advanced degree preferred
• Minimum of 5 years of experience in CQV within the pharmaceutical or biotechnology industry
• In-depth knowledge of cGMP regulations, including EU GMP Annex 1 and FDA aseptic processing guidelines
• Extensive experience with qualification of filling lines, clean utilities, and cleanroom systems
• Proficiency in risk management methodologies (e.g., FMEA, HACCP)
• Strong understanding of aseptic processing and sterilization techniques
• Experience with isolator technology and RABS (Restricted Access Barrier Systems)
• Familiarity with computerized system validation and 21 CFR Part 11 compliance
• Knowledge of statistical analysis and sampling plans for qualification activities
• Proficiency in technical writing and documentation
• Strong problem-solving skills and ability to work independently
• Excellent communication and interpersonal skills for effective collaboration

Preferred Qualifications

• Experience with project management tools and methodologies
• Familiarity with GAMP 5 guidelines for computerized systems
• Knowledge of continuous manufacturing processes
• Experience with single-use technologies in biopharmaceutical manufacturing
• Certification in Lean Six Sigma or other process improvement methodologies