GMP and Validation Expert, QA (m/f/d)
Join castus on the way to the top!
The castus group is a leading global provider of systems for sterile material transfer in aseptic pharmaceutical production, including transfer systems, ports and equipment. With castus Single Use Bags (CSU), our sterile single-use transfer bag, we are building a new, rapidly growing business segment.
Around 80 brilliant minds already work for us – and now we are looking for you! Are you a GMP expert with a passion for validation, quality, and aseptic processes? Then join our team, take charge of the validation of our sterile single-use transfer bags (CSU), and contribute your GMP expertise across the entire company!
Ochsenhausen, Germany
Full-time
Permanent
With immediate effect
This will make you grow:
- You will oversee the validation of our CSU products and coordinate testing with external laboratories, such as for extractables and leachables, particles, bioburden, shelf life, leak testing and sterilization.
- You will create and maintain validation dossiers as well as technical customer documentation.
- You will support customers in the qualification of our products, address technical and GMP-related requirements, and assist with customer audits.
- You will handle nonconformities, complaints, and CAPA actions, and be responsible for change control as well as the qualification of relevant suppliers.
- You will advise various internal departments - such as Development, Sales, and project teams - on GMP requirements for our entire product portfolio, particularly regarding EU GMP Annex 1, contamination control and equipment qualification.
- You will train employees on GMP topics and current regulatory requirements.
- You will monitor regulatory developments and strengthen our technical positioning through case studies, technical presentations, and technical articles.
This will move us forward:
- You have a degree in pharmacy, biotechnology, chemistry, microbiology, process engineering, or pharmaceutical engineering, or a comparable qualification.
- You have at least 5 years of professional experience in quality assurance or validation, ideally in the pharmaceutical industry or aseptic manufacturing.
- You have experience with GMP, EU-GMP Annex 1, validation, sterilization and ideally extractables and leachables, as well as sterile packaging.
- You are able to provide technical guidance to testing laboratories, evaluate test results and support customer audits.
- You work in a structured and independent way, communicate complex topics clearly and bring strong expertise.
- You are fluent in German and English and are willing to travel for client meetings and conferences.
That is why castus is a great place to work:
- You want to create, not just execute: At castus your ideas count and you’ll have the freedom to make a real impact.
- You thrive on variety: Every day is different here – your skills will be in constant demand.
- You don’t want to be just a number: With us, you’ll be part of a dedicated team with flat hierarchies and a personal, collaborative atmosphere!
Send your application preferably by e-mail to
Ms. Michaela Schuler · Phone: +49 7352 92187 - 190 · E-Mail: karriere@castus.pro
If you have any questions, please feel free to contact us at any time.
castus GmbH & Co. KG · Kolpingstr. 34 · 88416 Ochsenhausen · Germany
WORKING AT CASTUS Come and join our team!
Founded in 2011
80 employees
Pharma technology
Mid-sized company
Flat hierarchies
casual clothes
Career changers welcome
owner-managed