QA Specialist 3, QA Validation - LSA

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.

Join Lonza AG as our Quality Assurance Compliance Specialist 3 and be part of our outstanding team in New Hampshire, USA! This role will supply to our high-quality and engineering systems, ensuring the detailed execution of validations and qualifications for our brand-new facilities and equipment!

Key responsibilities:

• Lead the quality and engineering aspects of development, including the execution of qualifications, validations, re-qualifications, and re-validations for process equipment, laboratory equipment, utilities, and facilities.

• Support the review and approval of Validation/qualification/revalidation documents for systems such as incubators, BSCs, autoclaves, bioreactors, process gases, DI water systems, and classified clean rooms/HVAC (Grades A through D).

• Coordinate validation activities with manufacturing, QC, materials management, and engineering teams.

• Track and report the status and completion of action plans related to validation systems improvement efforts.

• Advocate for continuous improvements in Quality engineering systems, encompassing processes, equipment, facilities, utilities, and computer systems.

• Approve and release equipment-related deviations.

• Review and approve SOPs and master documents related to facilities and engineering.

• Serve as a vital resource for Quality, Engineering, Facilities, and Validation organizations.

• Perform project-related tasks as assigned.

• Undertake additional duties as required.

Key requirements:

• Proven experience in managing validation and qualification processes within a regulated environment.

• Outstanding ability to coordinate and communicate with diverse groups of individuals.

• Strong track record of implementing continuous improvement initiatives.

• In-depth understanding of quality engineering systems and compliance standards.

• Ability to strictly adhere to and enforce regulatory requirements and company policies.

• Demonstrated skills in tracking and reporting on project statuses and improvements.

• Relevant qualifications in engineering, life sciences, or a related field.

• Ability to successfully implement and coordinate validation systems and processes.

• Strong problem-solving abilities and ability to effectively manage tasks.

• Willingness to take on additional responsibilities as needed.

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.