Manufacturing Specialist Mammalian Large Scale

vor 3 Wochen

Visp, Schweiz Lonza Vollzeit

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.

Due to the growth at our site in Visp, we are currently looking for Manufacturing Specialists (m/f/d) for our Ibex-facility. In this role, you will be responsible for executing operational activities of assigned manufacturing in specific areas (Upstream (USP), Downstream (DSP) or Buffer Media and Production Support (BMS) processing) for a large scale 6x20kL Scale Drug Substance Mammalian facility.

Key responsibilities:

Execute manufacturing activities in either the Upstream Processing, Downstream Processing or Buffer Media and Production Support (BMS) areas according to cGMP guidelines, ensuring batch execution (organizing workload and assigning tasks to Biotechnologists), evaluating test results, ensuring completeness of production activities including IPC checks and sample delivery, resolving issues, troubleshoot manufacturing equipment and make recommendations for resolution. First point of contact for raising deviations and supporting root cause analysis, and escalating issues appropriately to the Team Lead Operations and area lead

Support the preparation of SHE (Safety, Health, environment), EM (Environmental Monitoring), operation and cleaning risk assessment for the assigned products and the implementation and control of defined measures

Support document preparation (e.g. electronic batch records, SOPs) specific to the assigned production area

Review production documentation and work on deviations, change requests and implementation of CAPAs to ensure high-quality GMP standards

Responsible for the training of the manufacturing staff on specific equipment or standard operations

Working as production expert in Capital investment projects for building and commissioning of the manufacturing units

Responsible for delivering all input required for the specific set-up, commissioning and qualification of the manufacturing suites and equipment including automation

Executes real-time batch record review, including issue resolution with QA and manufacturing leads

Key requirements:

Bachelor or Master's degree in Biotechnology, Bio-chemical Engineering or related disciplines

Sound knowledge of biotechnological processes in large scale mammalian/microbial inoculation and cell culture, harvest, buffer / media preparation in stainless tank transfer to stainless hold tanks, and transfers to single use technologies, parts preparation (washer/autoclaves), large powder dispensing and/or in protein purification (Chromatography on 1-2M columns, TFF, SPTFF, Depth filtration, VRF, VI,& End fill operations)

In depth cGMP understanding is highly advantageous for the role

Fluency in English mandatory, German is highly desired

Open to work in shift (4-shift system)

Excellent communication skills, team player, driven and solution-oriented

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: R59351

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