Commissioning and Qualification Specialist

3 months ago

Slough, United Kingdom Lonza Full time

United Kingdom, SloughCommissioning and Qualification Specialist

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.

In order to upskill our wider Validation team, we are now looking to hire a Commissioning and Qualification Specialist for our Slough site. This represents an amazing opportunity to join a team in a fast-paced environment with fantastic potential for growth and development, in a role with excellent variety, where there’s always a new challenge to overcome Your role involves working with equipment in manufacturing, laboratory and warehouse areas in a combination of hands-on and office-based work.

Key responsibilities:

- Generation and execution of commissioning and qualification lifecycle documentation in line with cGMP, industry best practice and Lonza policy, for equipment and utilities that include:

- Temperature controlled equipment
- Automated manufacturing systems
- SIP and CIP systems
- HVAC
- Manual and automated cleaning methods
- Execute routine and project commissioning and qualification work related to utilities, sterilization, biopharmaceutical manufacturing equipment (cell culture, downstream purification, filling and packaging) and controlled storage equipment installed on site
- Prepare and review impact assessments, plans, protocols and reports.
- Contribute towards raising and supporting Deviation, CAPA, Out Of Specification (OOS) and Out Of Trend (OOT) investigations.
- Support the validation team in root cause analysis for technical issues.

Key requirements:

- Prior experience in a validation function in a Biologics / Pharmaceutical or related industry
- BSc or equivalent qualification in a scientific, engineering, technical, or other related field
- Knowledge and understanding of Regulatory GMP guidelines
- Ability to work on several projects / tasks at the same time

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.

Reference: R53638

LI-IG1

**Reference: R53638**:

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