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 Specialist is responsible for supporting efforts that ensure all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines. The specialist works closely with 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.  At this level the specialist must possess a full grasp of the duties of Validation and serve as a role model and resource to less experienced staff on the team.  Additionally, the Specialist at this level will support the team in the manager’s absence and may be assigned special projects while maintaining their regular duties.

Key responsibilities:

  • Develop complex equipment validation strategies and execute intricate validation qualifications.  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 Level 1, Level 2 and Level 3 Specialists as determined by Management.
  • 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 including Data Acquisition systems for temperature mapping 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.).
  • Mentor Level 1, 2 and 3 Specialist
  • Perform other duties as assigned.

Key requirements:

  • Bachelor’s degree in Science or technical discipline required.
  • Detailed knowledge and understanding of regulatory requirements, biopharmaceutical sterile drug product manufacturing and quality assurance operations.
  • Strong knowledge in the application of cGMP requirements, biomanufacturing processes, and purpose and function of manufacturing equipment and processes.
  • Understanding of facility design requirements and GMP to show the design as delivered is fit for use. Understanding of validation/qualification principles, industry practices, and standards with ability to apply these to GMP operations.
  • Understanding of the principles of biologics manufacturing.
  • Demonstrated ability to lead teams of diverse skill sets, make sound decisions regarding evaluation of validation programs, and abilities to influence at various levels in a cross-functional organization.
  • Able to manage large, complex projects to successful conclusion.

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: R32877