CSV Engineer

Description

Reference #: 915311NC
Industry: Pharmaceuticals
Location: Basel und Region
Start:
Duration:
Workload: 100%

RESPONSIBILITIES:
-Manage, co-ordinate, develop and execute the validation deliverables for a new IS project.
-Support and co-ordinate the qualification and validation processes.
-Support activities include, but are not limited to; the preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPs and Change controls.
-Facilitate the release of the regulated system for GxP production use in line with project timelines. Support the resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.)
-Participate in required project teams
-Will be responsible for defining test strategy, designing and developing test cases from software requirements, architecture designs, and code of complex software systems.
-Conduct validation training with project team communicating deliverables, procedures and methods

QUALIFICATIONS / REQUIRED EXPERIENCE
-Bachelor's degree in Automation Engineering, Electrical Engineering, Systems Engineering, Technology or a related discipline.
-At least 3 years of industry experience in software engineering
-Software Validation and Equipment Validation experience in a regulated industry: FDA 21 CFR 820, the Quality System Regulation and ISO 13485.
-Experience of GxP Computerised Systems
-Understanding of GAMP5 Guidelines.
-Validation experience with ERP, CCMS/CMMS, and Quality Systems is preferred
-Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required
-Strong knowledge of computerized system development life cycle approach is required