CSV Engineer

2 weeks ago

College Station, United States Metric Bio Full time

We are partnering with a global leader in biotechnology, renowned for its cutting-edge advancements in the life sciences sector. Our client is seeking a highly skilled CSV Engineer with extensive experience Process Analytical Quality (PAQ) controls, to join their team.


About the job


CSV Engineer

College Station, TX


To be successful you will have a deep understanding of Computer System Validation (CSV) and Process Analytical Quality (PAQ) controls, along with the ability to manage validation deliverables in compliance with industry regulations such as 21 CFR Part 11, Annex 11, Data Integrity, and GAMP5. The ideal candidate will lead validation efforts, assess existing programs, and ensure adherence to regulatory standards.


  • Validation Management: Lead the development, approval, and execution of validation deliverables for computerized systems and infrastructure, including but not limited to Validation Plans, Requirements Specifications, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports.
  • Regulatory Compliance: Ensure that all validation activities and documentation comply with regulatory standards such as 21 CFR Part 11, Annex 11, Data Integrity, and GAMP5. Stay current with changes in regulations and industry best practices.
  • Program Assessment & Gap Analysis: Conduct comprehensive assessments of existing CSV/PAQ programs, identify gaps, and develop actionable plans to address deficiencies.
  • Cross-Functional Coordination: Plan and coordinate validation activities across multiple departments, providing regular updates and ensuring alignment with project timelines and operational needs.
  • Independent Execution: Work independently to author, execute, and analyze validation protocols and reports, with minimal supervision from Senior Engineers or the CSV Manager.
  • Document Review & Quality Assurance: Review System Development Life Cycle (SDLC) deliverables for accuracy and compliance. Provide constructive feedback to ensure adherence to Standard Operating Procedures (SOPs) and regulatory requirements.
  • Training & Mentorship: Train and mentor team members on CSV/PAQ processes, regulatory compliance, and best practices to enhance overall team capability.
  • Continuous Improvement: Identify opportunities for improving validation processes and systems. Drive initiatives to enhance the efficiency and effectiveness of CSV/PAQ practices.
  • Ethical Compliance: Perform all duties in an ethical manner, in accordance with applicable laws, regulations, and industry codes.
  • Additional Responsibilities: Undertake other duties as assigned to support the team and organization’s goals.


Required Qualifications

  • Bachelor’s degree in Life Sciences, Engineering, or a related field. Advanced degree preferred.
  • 4+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments
  • Strong knowledge of DeltaV, DCS, SCADA, BMS systems, and relevant software platforms.
  • Familiarity with engineering principles and computerized systems validation.
  • In-depth understanding of 21 CFR Part 11, Annex 11, Data Integrity, and GAMP5.


Sounds like a fit? Click apply.


Please note, you will only be considered if you have the required experience listed.

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