Validation Engineer

Westborough, MA

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Perm Opportunity

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Validation Engineer with 2+ years of experience to provide validation and documentation support. Incumbent will be responsible for review and update of system life cycle documents (URS, FS, HDS, SDS), creation of traceability matrices, and the creation of test plans.

This individual will also be responsible for the execution of test procedures and review of executed test plans.

Essential Responsibilities: Assess and record requests for assistance. Gather necessary information and identify personnel required for assistance Understand customer standard operating procedures Communicate information back to responsible parties Update system documents based on new product releases Assist in the development of engineering change requests Perform an impact assessment on documents based on system modifications K

nowledge, Abilities, Skills: Read and understand system life cycle documents such as the User Requirements Specification (URS), Functional Specification (FS), and Software Design Specification (SDS) Familiarity with equipment used in a Biotech facility such as Bioreactors, Mixing Tanks, Filtration Systems, Clean Utilities, and CIP is a plus Knowledge of Good Automated Manufacturing Practice (GaMP) Knowledge of Good Documentation Practice (GDP) Familiarity with automation equipment such as Programmable Logic Controllers (PLCs) is a plus

Requirements: Bachelor’s Degree in Engineering 2+ years of validation experience Knowledge of Good Automated Manufacturing Practice (GaMP)

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