Description
Our global pharmaceutical client is looking for an experienced Computer System Validation Engineer to join their team and support the CSV of the manufacturing applications.The successful candidate will be responsible for the remediation and revalidation of computer systems with regards to Annex 11. We are looking for a proactive team player who can integrate into a global environment.
Responsibilities:
• Review computer system validation documents.
• Ensure gap analysis has been performed against global computerised system validation policies and issues have been resolved.
• Maintain and develop current validation procedures, implementing improvements wherever possible.
Requirements:
• Previous experience working as CSV Engineer within the Pharmaceutical/Bio-pharmaceutical industry, with knowledge of FDA and cGMP requirements.
• Experience performing gap analysis.
• Strong knowledge of Annex 11.
• German language skills required
• Personal attributes include flexibility, self-motivated, team player and proactive.
The successful CSV Engineer will have the chance to work in a very reputable company within the Pharmaceutical industry during a very exciting period of projects and receive competitive rates of pay.