Equipment Validation Specialist

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 Practice) equipment 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 Maintenance Quality Systems review and re-qualification activities to ensure GMP equipment is continuously maintained in a validated state.  Schedule own tasks to be performed as well as tasks for other Specialists as determined by the Validation Manager

  • Perform change control assessments for GMP equipment and associated validation activities to ensure compliance with regulatory requirements

  • Program, organize, and maintain Validation equipment and supplies and train new personnel in these areas

  • Demonstrate a thorough understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Qualification (IQ), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment.  Develop validation protocols from Validation plans and engineering documents

  • Provide strong technical expertise when reviewing and approving SOPs, protocols, change controls, deviations

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

  • Perform other duties as assigned

Key requirements:

  • Bachelor’s Degree in Science or technical discipline

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

  • Strong written and oral communication skills and ability to work interdepartmentally with very minimal supervision in an effective manner to carry out daily duties. 

  • Understand how to write discrepancies, give a root cause analysis and perform Quality Risk Assessments.

  • Strong 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: R41020
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