CSV Engineer
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Job Location:
Raritan, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
Position: CSV Engineer
Location: Raritan NJ(Hybrid-Onsite 3 Days in a Week)
Duration: 1 Years
Mandatory - Computer System Validation Mergers & Acquisitions / Separation or Divestiture related Application SDLC management
Job Details
Must be able to support Business Separation activities for Large global & regional GxP Computerized systems.
Strong CSV Expertise especially within Acquisition/ Divestiture/ Separation.
Ability to manage end-end from Inventory assessments remediations to final dispositions;
7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources - Specifically in the Pharmaceutical biotechnology or medical device industry.
Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation;
Define and implement Risk based validation activities. Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements Compliance/validation Plans test protocols Test Summary reports and Compliance/Validation Reports SOPs/WIs).
Experience in reviewing system test and user acceptance test scripts Traceability matrix and Design Specs Experience in QA Methodologies designing reviewing and approving Test Plans systems and UAT test scripts and Test procedures.
Strong verbal and written communication skills.
Ability to work as a team player lead a team or accomplish tasks without supervision.
Possesses strong communication skills to interact with business stake holders (Technology Leader Project Manager Business Owner & Business users / SME) and interpret business rules and requirements and documents them for software development.
Ability to work with project team to facilitate interaction between Project team and Business Stake holders.
Manage Project priorities based upon identified risks.
