Bioprocess Engineer, Cleaning Expert
vor 3 Wochen
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.
The site in is growing and for our Biologics organization, we are currently looking for aBioprocess Engineer, Cleaning Expert. Lonza has a strongtrack recordin the manufacturing ofBioConjugatesfrom early clinical to large scale commercial supplies. Our dedicated Protein Conjugation Plant facility (PCP) is recognized as a center of excellence for Antibody Drug Conjugates (ADC) as well as other classes ofBioConjugates. Become part of this exciting opportunity and apply now
Key Accountabilities and Duties:
Lead the cleaning concept of the process equipment for module L
Responsible to prepare and execute cleaning risk analysis for the assigned products and the implementation and control of defined measures.
Understands and supports timely and with high quality the required production documentation (preparation and review of electronic batch records) specific to cleaning.
With focus on cleaning of equipment perform manufacturing activities according to cGMP guidelines, ensuring batch execution, evaluating test results, resolving issues, troubleshoot manufacturing equipment and make recommendations for resolution.
Reviews production documentation and works on deviations, change requests and implementation of CAPAs to ensure high-quality GMP standards.
Ensure cleaning processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle
Prepares, changes and reviews DeltaV recipes for equipment and facility parts.
Executes innovation and improvement projects comprising general cleaning aspects for the production plant.
Responsible for training of the operators for cleaning related tasks as e.g. swabbing and visual inspection
Represents own area / unit during customer audits and visits
Perform other duties as assigned.
Required Qualifications:
Master Degree / PhD
Preferred area of study: Biotechnology, Biochemistry or related disciplines
MS: no industrial working experience in this area required
BS (3-5 years experience)
Good biotechnology expertise and/or knowledge in biotechnical engineering preferable in the area of microbial fermentation; fluent in German/English; basic GMP understanding
Good knowledge of USP/ DSP equipment design.
Previous experience in equipment cleaning topics is highly desired.
Good leadership skills; good communication skills and interaction with all kinds of interfaces within the organization; strong team orientation
Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; high motivation and dynamic drive; 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: R60013-
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