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VNSURE BUSINESS SOLUTIONS PRIVATE LIMITED · 4 weeks ago

Validation Engineer II

porstmouth, NH

Full-time

Hybrid

Mid Level

VNSURE BUSINESS SOLUTIONS PRIVATE LIMITED is seeking a Validation Engineer II to enhance compliance and efficiency in their processes. The role involves implementing best practices in validation, risk assessing systems, and managing documentation revisions while ensuring adherence to regulatory standards.

ConsultingHuman ResourcesStaffing Agency

Responsibilities

Identify and implement industry best practices through an extensive industry network and detailed knowledge of applicable regulations

Work with other experienced members of the CSV team to identify roadblocks and additional efficiencies

Risk assessing systems

Reviewing change requests and test scripts

Drafting protocols

Initiating and reviewing GMP documentation revisions

Execute all responsibilities as the CSV owner for significant site and process improvement projects

Ensure compliance to appropriate regulatory requirements and industry standards while maximizing efficiency

Perform all aspects of the QMS process – Change Control (particularly associated with DCS ( DeltaV) and MES ( Syncade) systems, Deviations, CAPAs

Perform other duties as assigned

Qualification

Equipment validationComputer validationControls AutomationProcess Control SystemsManufacturing Execution SystemsBiotech/Pharma experienceDeadline managementAttention to detailIndependent work

Required

Substantial experience in equipment and/or computer validations

Must have Working experience with Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES) required, DeltaV preferred

Prior experience leading projects in a Biotech/Pharma or biologics industry

Strong attention to detail and ability to work independently and meet deadlines successfully