Commissioning & Qualification Manager

2 days ago

Lightwater, United Kingdom Lonza Full time
United Kingdom, Slough

Job Title: Commissioning and Qualification Technician
Location: Slough, UK

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.

Role Purpose:

Working as part of the Validation Team, this role involves execution of Commissioning and Qualification project plans and protocols, in line with cGMP, industry best practice and Lonza policy to Commission and Qualify equipment and utilities to include:

Ø temperature controlled storage environments,

Ø automated manufacturing systems,

Ø sterilization systems,

Ø SIP and CIP systems,

Ø Utilities,

Ø HVAC and manual and automated cleaning methods, in a biopharmaceutical manufacturing plant.

Key Accountabilities and Duties:
  • This role provides a combination of hands-on and office based work and involves access to equipment in manufacturing, laboratory and warehouse areas.
  • Responsible for the execution of commissioning and qualification project plans and protocols, according to current GMP regulations and guidelines, industry best practice and company policy.
  • 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
  • Contribute to root cause analysis for technical issues
  • Contribute to process/method improvements and suggestions
  • Report progress to the validation scheduler, line manager and internal customers to ensure validation activities are aligned with Quality Assurance, Quality Control, Manufacturing, Technical services, Development services and Asset maintenance
  • Maintain an up to date training profile
  • Perform other duties as assigned/required to support the objectives of the Validation Team.

Qualifications:

Degree (preferred) BSc or Equivalent Field of Study Mechanical Engineering, Chemical Engineering, Electronic/Electrical Engineering, Automation, Science/Engineering degree.

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: R62209

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