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CSV Engineer
Eingestellt von Optimus Search
Gesuchte Skills: Engineering, Engineer, Erp
Projektbeschreibung
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!
(see below)
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!
(see below)
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Ingenieurwesen/Technik