Commissioning and Qualification Specialist

Lonza; Slough; On-site; GBP 35,000 - 65,000; Full time

Job description

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.

The role:

Join us as a Commissioning and Qualification Specialist, pivotal in ensuring flawless operations at our biopharmaceutical manufacturing plant in Slough, UK. Working as part of the Commissioning, Qualification, and Validation (CQV) Department, this role involves generating and executing commissioning and qualification lifecycle documentation in line with Good Manufacturing Practices (GMP), to commission and qualify equipment and utilities. You will be responsible for temperature-controlled equipment, automated manufacturing systems, sterilisation systems, and manual and automated cleaning methods, in a biopharmaceutical manufacturing plant.

Please note that experience in Sterilisation Systems and Temperature Mapping of controlled equipment are essential for this role!

Key responsibilities:

• Complete commissioning and qualification project plans, protocols, and reports in alignment with GMP regulations, industry standards, and Lonza policy.
• Complete routine and project commissioning and qualification tasks related to utilities, sterilisation, biopharmaceutical manufacturing equipment (such as cell culture, downstream purification, filling and packaging), and controlled storage equipment.
• Prepare and review impact assessments, plans, protocols, and reports to ensure world-class standards.
• Support and contribute to Deviation, CAPA, Out Of Specification (OOS) and Out Of Trend (OOT) investigations with proven problem-solving skills.
• Perform root cause analysis for technical issues to determine and implement effective solutions.
• Propose and contribute to process and method improvements, demonstrating an ambitious and proactive approach.
• Coordinate with the validation scheduler, line manager, and internal customers to align validation activities with QA, Quality Control, Manufacturing, Technical Services, Development Services, and Asset Maintenance.
• Maintain an up-to-date training profile to ensure compliance with all necessary safety assessments and training standards.
• Perform additional duties as required to support the objectives of the CQV department.

Key requirements:

• BSc or MSc in Mechanical Engineering, Chemical Engineering, Electronic/Electrical Engineering, or Automation, or equivalent experience.
• Candidates must have extensive experience in Sterilisation Systems and Temperature Mapping of controlled equipment for this role!
• Demonstrated ability to challenge the status quo and find opportunities for improvement within and beyond your area of expertise.
• Proven track record of embracing new initiatives and driving their successful implementation.
• Comprehensive knowledge of Regulatory and cGMP guidelines, with the ability to contribute to quality records (Deviations, Investigations, CAPA, and Change Control).
• Dedication to carrying out necessary safety assessments and maintaining a high standard of safety training, with the ability to manage safety incidents effectively.

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.