CQV Engineer IV, Quality Control - Allogenic

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.

Job Summary :

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.

Key Responsibilities :

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 walkthrough 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.

Perform 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

Develop and revise validation related standard operating procedures (SOPs) for manufacturing equipment, process support equipment, etc

Support work orders, maintenance plans, and other items in the computerized maintenance management system (CMMS)

Work closely with cross-functional teams including engineering, quality assurance, manufacturing, and other stakeholders

Performs all aspects of QMS process' – Change Control, Deviations, CAPAs, Tasks Writes, reviews, assesses, and / or approves change controls for analytical instruments and software used in QC laboratories and manufacturing

Remain up to date on all assigned training activities

Perform other duties as assigned

Key Requirements :

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.

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