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Computer System Validation

4 months ago

College Station, United States BioPharma Consulting JAD Group Full time
Job DescriptionJob Description

Summary: BioPharma Consulting JAD Group is seeking a Computer System Validation (CSV) Engineer III to join our team. As a CSV Engineer III, you will be responsible for ensuring compliance with regulatory requirements and industry standards for computerized systems used in pharmaceutical manufacturing processes. You will work closely with cross-functional teams to plan and execute computer system validation activities and ensure the integrity of data generated by these systems.

Functions:

  • Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others.
  • Plan and organize validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work
  • Able to work independently with minimum guidance from Sr. Engineers and/or CSV Manager (author protocol, execute, analyze data, author reports).
  • Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs).
  • Must be able to create, review, and update SOPs, forms, templates, documentation and files.
  • Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation, and industry codes.
  • Perform other duties as assigned.

Required Skills & Abilities:

  • Working knowledge of engineering principles.
  • Working knowledge and expertise in computerized systems validation.
  • Computer System Validation experience with DCS, SCADA and BMS systems such as DeltaV, Factory Talk View, Desigo, Unicorn, Wonderware is preferred.
  • Knowledge of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements and FDA industry regulations.
  • Excellent written and oral communication skills.
  • Working knowledge and experience in Microsoft Office products (Outlook, Word, Excel, Power Point).
  • Ability to work with minimal supervision.
  • Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.

Requirements

Qualifications:

  • Master’s Degree with two (2) years of direct experience in Validation in a pharmaceutical, biotechnology, or
  • Bachelor’s Degree with four (4) years of direct experience in Validation in a pharmaceutical, biotechnology, or
  • Associate's Degree with six (6) years of direct experience in Validation in a pharmaceutical, biotechnology

Preferred Qualifications:

  • Knowledge of DeltaV automation platform.
  • Experience preferably in FDA-regulated environments.