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Senior CSV Engineer

2 months ago

College Station, United States Technical Source Full time
Job DescriptionJob Description

Technical Source is currently in search of a Senior CSV Engineer for our CDMO client located in Texas for a 12 month contract position. The qualified candidate will have 5-7 years' experience with Computer Systems validation activities in pharmaceutical, biotechnology, or other regulated environments. The individual with act as a CSV subject matter expert creating and executing validation deliverables for computerized systems and relevant infrastructure.

***We can not accept 3rd party candidates for this position.

Responsibilities of the Senior CSV Engineer Include:

  • End-to-End Validation: Spearhead the creation and execution of validation plans, including URS/FS/DS, System Impact Assessments, Risk Assessments, Installation and Operational Qualifications, Data Migration Plans, and Electronic Records/Signatures Assessments.
  • Document Generation and Approval: Produce, obtain approvals for, and execute validation deliverables such as Validation Plans, Requirements Specifications, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports. Ensure all documentation meets regulatory and procedural requirements (21 CFR Part-11, Annex-11 Data Integrity, and GAMP5).
  • Cross-Functional Coordination: Plan and organize validation activities across various teams, providing regular status updates for ongoing operations and project work.
  • Review and Feedback: Evaluate all System Delivery Life Cycle (SDLC) deliverables, offering constructive feedback to ensure compliance with Standard Operating Procedures (SOPs).
  • SOP Management: Develop, review, and update SOPs, forms, templates, documentation, and files.
  • Audit Support: Act as a CSV subject matter expert during regulatory and client audits.
  • Additional Duties: Perform other duties as assigned to support the team and company goals.

Qualifications Include:

  • Educational Background:
    • Master's Degree in Computer Science, Life Sciences, Engineering, or a related discipline with 3+ years of CSV experience in pharmaceutical, biotechnology, or related industries.
    • Bachelor's Degree in similar fields with 5+ years of CSV experience.
    • Associate Degree with 7+ years of CSV experience.
  • Technical Expertise:
    • Knowledge of the DeltaV automation platform preferred.
    • Proficiency in engineering principles and computerized systems validation.
    • Experience with DCS, SCADA, and BMS systems such as DeltaV, Factory Talk View, Desigo, Unicorn, and Wonderware is preferred.
    • Comprehensive understanding of 21 CFR Part 11, Annex 11, Data Integrity, GAMP5 requirements, and FDA industry regulations.
  • Communication and Software Skills:
    • Excellent written and oral communication skills.
    • Proficient in Microsoft Office products (Outlook, Word, Excel, PowerPoint).
  • Work Ethic and Values:
    • Ability to work independently with minimal supervision.
    • Eagerness to thrive in a dynamic, state-of-the-art research and customized manufacturing environment.

Key Words:

Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), SOP, 21 CRF Part 11, Annex 11, biologics, CSV, regulatory, compliance