Beschreibung
Are you a CSV Engineer interested in working for one of Switzerlands leading names in High-Tech Pharmaceutical Engineering?
Are you looking for something new?!
Then stop what you are doing and read on!
Title: CSV Engineer
Rate: Negotiable
Location: Switzerlands
Positions Available: 2
Type: Contract (18 Months Rolling)
A Fantastic new role has just opened up at one of our leading Swiss based clients offering the successful candidate the opportunity to join a hard-working team working on exciting projects in the pharmaceutical sector.
The proposed start date is ASAP - We need YOU
Responsibilities include:
- Independent planning, implementation and coordination of customer-oriented compliance projects
- Creation of system life cycle documents (FS, HDS, SDS)
- Evaluation of GMP systems according to E-Compliance
- Risk management across all process phases as well as systems
- Supervision of supplier audits
- Support for GMP-specific change management
- Validation of software and qualification of hardware
Requirements:
- At least 3 years of professional experience in the areas of qualification/validation/quality management of computer-assisted systems (CSV) or plant qualification in the GMP-regulated industry
- Graduate in Business Informatics/Mechanical Engineering/Electrical and/or Communication Engineering or a comparable degree
- General project management competence as well as IT knowledge in process automation, STEP7, Delta V, SCADA, PCS, MES, LIMS and ERP
- Data management knowledge
- Sound knowledge of regulatory requirements (FDA, EMA, ANNEX11, SwissMedic, AMG)
- In-depth GMP and GAMP5 knowledge
- You are a powerful, highly motivated and committed personality and possess
- Excellent German and English skills both written and spoken
If you are interested please do not hesitate to email or call me!
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