QA Contamination Prevention Manager (f/m/d)

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.

This role is based in BioAtrium, which is a joint venture and part of Ibex® Solutions (www.ibex.lonza.com).

Ibex® is a modular build complex to develop and manufacture biological products.

It enables companies to get access to a complete solution, gaining speed and achieving a simplified value chain.

The Ibex® Complex is our contribution to the medicine of tomorrow and possibly the next step in your career? Start your career with Lonza today.

Apply as QA Contamination Prevention Manager (f/m/d)!

Key responsibilities:


* Ensuring the development of an end-to-end microbial control concept for the biotechnological drug substance manufacturing facilities and capturing it in local documents (incl.

specifications, SOPs, etc.)


* Ensure that practices within the manufacturing facility are compliant and support microbiological control of the product


* Ensuring a robust contamination control strategy is in place


* Supporting the Quality Oversight on activities of Environmental Monitoring and activities related to the assessment of disinfectants from microbiological expertise point of view


* Writing, Reviewing and approving SOPs, deviation reports and change requests, associated with the above-mentioned topics


* Supporting the preparation and follow-up of customer audits and regulatory inspections


* Acting as an expert during audits / inspections, presenting aspects related to the microbial control and sterility strategies


* Enhancing the quality knowledge by following the quality standards and by visiting specific training courses / conferences

Key requirements:


* University degree (Bachelor, Master or PhD) in pharmacy, engineering, natural science, or related life sciences discipline - preferably microbiology


* Substantial experience in the area of biopharmaceutical manufacturing and a strong background in cGMP


* Broad knowledge related to hygiene topics, environmental monitoring, disinfectant testing and microbial control strategies


* Previous Contamination Control experience, would be an advantage


* Good communication skills and interaction with all kind of interfaces within the organization and  regulatory agencies (e.g.

US FDA, EMA, etc.)


* Working knowledge with MS Office, Excel, data trend creation/analysis, TrackWise®, LIMS and SAP is an advantage


* Fluent in English, German is an advantage

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 grea...