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Sr. Validation Engineer
MA
Duration: Open (long term)
Job Description:
Develop and execute Computerized System Validation (CSV) deliverables for control systems, DeltaV, SCADA, PLC for production equipment including but not limited to Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Trace Matrices, Test Execution, Summary reports. CSV will be specific to automated process equipment and interfaces.
Requirements:
Education: Bachelor's degree in Engineering or related science studies.
Minimum five 8+ years related work experience including strong knowledge and hands-on experience of computer system validation (CSV) activities in the regulated industries.
Strong technical writing skills
Essential skills:
Understanding and experience with CSV regulations and guidelines such as FDA; cGMP for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, Data Integrity and Compliance with CGMP Guidance for Industry; and ISPE GAMP5.
Strong knowledge of the development and execution of CSV deliverables throughout the System Development Life Cycle (SDLC) Knowledge, familiarity and exposure to industrial control systems (PCS, Siemens PLC, or related), including related configuration/programming.
Strong technical writing skills.
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