Validation Specialist (EQV)

United States, Portsmouth (New Hampshire)

Today, Lonza is a global leader in life sciences operating across three 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.

QA Equipment Validation exists to ensure all critical GMP (Good Manufacturing Procequipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines. We provide Operations, Quality Assurance, our clientele, and regulatory bodies with scientifically sound, documented evidence that our systems and processes will perform as required so they can be assured of a quality, compliant manufacturing environment. 

Key responsibilities:

  • Perform Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in a validated state.

  •  Program, organize, and maintain Validation equipment and supplies including dataloggers and probes.

  • Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV/IQ), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment.

  • Develop validation protocols from plans and engineering documents.

  • Provide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etc

  • Perform assigned Quality Systems activities within Document Management System (DMS), Laboratory Information Management System (LIMS), and Trackwise Quality System (Change Control, Deviation, CAPA)

Key requirements:

  • Bachelors Degree, Science or technical discipline.

  • Solid technical writing skills and ability to document all work in a meticulous, accurate, and timely manner. 

  • Solid written and oral communication skills and ability to work interdepartmentally with some basic supervision in an effective manner to carry out daily duties. 

  • Understand how to write discrepancies and give a root cause analysis..

  • Solid organizational and time management skills

  • Experience with Quality Systems including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control, Deviations, CAPA, etc.).

  • Demonstrates ability to prioritize tasks as needed to support the changing business demands.

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. 

Reference: R37041
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