GerTEK Project Management & Technical Services are hiring for an experienced CSV Engineer
- Review/Approval of all Computer Systems/Software Validation Documentation.
- Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems from a Computer Systems/Software Validation perspective to ensure their continued validated/qualified state.
- Represent Quality at new product project meetings
- Report and help resolve issues with respect to CSV Projects
- Ensure Quality System documentation is thorough, complete, and compliant including documents for new products.
- Development of life cycle documents necessary to address the validation lifecycle for Information Systems and GxP software systems (Planning, Risk, Implementation, and maintenance of the validated state).
- Performs effective document review to support Automation Compliance activities.
- Generate 21 CFR Part11 and Annex 11 Assessments for CSV Projects.
- Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary.
- Development and execution of the qualification for Information Systems and GxP software systems.
- Identify GAPs in Project delivery and report to Management
- Maintain and support proactive communications regarding automation related activities to ensure conformance and maintain related work schedules.
Qualifications & Key requirements
- Bachelor’s degree in relevant Science or Engineering.
- 3 year plus experience working in a highly regulated combination product/medical device / pharma manufacturing environment.
- Experience of production and laboratory systems beneficial. Knowledge around MES, SAP, Plant Data Historian, Metrology Instruments and associated software.
- Experience of IT infrastructure qualification as per regulatory requirements beneficial.
Job Type: Full-time
Schedule:
Work Location: In person
