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

GerTEK Project Management and Technical Services

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