CQV Engineer IV, Quality Control - Allogenic

CQV Engineer IV, Quality Control - Allogenic

United States, Portsmouth (New Hampshire)

The Commissioning, Qualification and Validation (CQV) Engineer IV supports the commissioning and qualification of equipment and systems. This role performs validation activities to include but not limited to equipment set up, managing protocols, maintenance (PRVM), and reviewing documents. This role ensures equipment and systems comply with regulatory requirements and quality standards.

• Configures, tests, and validates electronic systems to ensure the systems are properly commissioned/qualified and validated per standards and regulatory requirements (e.g., FDA, EU)
• Reads piping & instrumentation diagrams (P&IDs) to walk through systems in the field
• Develops, executes and manages equipment and system qualifications, validation protocols for manufacturing equipment, process support equipment (Bioreactors, clean steam generators, AHU) etc.
• Performs Periodic Review and Validation Maintenance (PRVM) for manufacturing equipment, process support equipment, etc.
• Identifies and assesses risks and escalates to management to develop and implement mitigation strategies
• Develops and revises validation related standard operating procedures (SOPs) for manufacturing equipment, process support equipment, etc.
• Supports work orders, maintenance plans, and other items in the computerized maintenance management system (CMMS)
• Works closely with cross‑functional teams including engineering, quality assurance, manufacturing, and other stakeholders
• Performs all aspects of QMS processes – change control, deviations, CAPAs, task writes, reviews, assessments, and/or approvals of change controls for analytical instruments and software used in QC laboratories and manufacturing
• Remains up to date on all assigned training activities
• Performs other duties as assigned

• Associate’s Degree in Chemistry, Computer Systems or related fields is required;
  Bachelor’s or Master’s Degree is preferred
• 5‑10 years of experience within a regulated environment
• Experience in Commissioning, Qualification and Validation
• Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing
• Experience with Data Integrity and 21 CFR Part 11
• Ability to work and communicate in a team environment
• Ability to think critically and logically

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.