(Senior) Consultant CSV (m/w/d)
- Heidelberg, Leipzig, Norderstedt, Stuttgart, Wiesbaden
- Full-time
- Permanent

The Chemgineering Group is a global consulting and engineering company with branches in Switzerland, Germany, Austria, Spain, Mexico, Poland and Serbia. As specialists for efficient processes, we design and implement demanding projects for various industries in the fields of pharmaceuticals, biotechnology, fine chemicals, medical technology, cosmetics, vitamins, diagnostics and food.
Your Tasks
- Implementation of challenging and varied consulting projects in information technology with a focus on CSV for our customers in the life science industry
- Development of individual CSV consulting concepts and their implementation with our customers, e.g. based on GAMP5
- Supporting our customers with technical expertise in ongoing CSV projects (e.g. for ERP, MES, LIMS systems, automation projects or complex laboratory/analysis equipment), including in the field of IT infrastructure qualification
- Creation of the necessary life cycle documents in collaboration with the customer team
- Carrying out fit/gap analyses, workshops or supplier audits as well as implementing and processing CAPA plans
- Support in the acquisition of CSV projects, e.g. participation in the preparation of offers
Your Profile
- Completed scientific or engineering studies (pharmaceutical, process engineering, chemistry or comparable) or business informatics or comparable and several years of professional experience in the life science industry
- Practical experience in the validation of computerized systems (e.g. ERP systems, LIMS, MES, laboratory equipment software, SCADA, ...) and knowledge of quality management
- Knowledge of the relevant legal principles and guidelines, in particular EU-GMP with Annex 11/15, GAMP5, 21 CFR Part 11/211/820 as well as ISO9000ff and ISO13485
- Willingness to travel nationally and internationally
- Good knowledge of German and English (written and spoken) is a prerequisite
Your advantages at Chemgineering
Flexible Working Hours
Hybrid Work
30 days vacation plus special leave
Individual Training Opportunities
Employee Discount
Attractive fringe benefits
Team Events
Apply now!
With our international teams, we carry out demanding consulting and planning projects and develop innovative solutions for well-known customers from the life sciences. Whether for innovative cancer therapies or in the complex regulations of the chemical, pharmaceutical and biotechnological industry - in this environment we offer you many career opportunities and excellent conditions for long-term development.
A family-friendly company with short lines of communication, a lot of creative freedom and a family corporate culture are waiting for you!
Apply now!
Kontakt
Andrea NikolausHuman Resources Professional
Tel: +49 (611) 7788 789
career@chemgineering.com
www.chemgineering.com