Automation Validation Engineer

2 weeks ago

College Station, Texas, United States Salent Solutions Full time
CSV Engineer - Automation

Company: Salent Solutions

Compensation: Commensurate with Experience

About this opportunity:

Salent Solutions is dedicated to providing commissioning, qualification, and validation services tailored for the biotech and pharmaceutical sectors. Our commitment lies in delivering exceptional service to organizations that develop life-saving medications. If you are eager to engage in cutting-edge life sciences initiatives, this position may be ideal for you.

We are in search of a driven and knowledgeable CSV Engineer with a focus on automation and a robust background in DeltaV systems. The selected candidate will play a crucial role in ensuring that our automated systems adhere to regulatory mandates and industry benchmarks through thorough computer system validation procedures.

Key Responsibilities:
  1. CSV Activities:
    • Design, develop, and implement computer system validation (CSV) protocols and tasks for automated systems, especially DeltaV.
    • Draft and evaluate validation documentation, which includes user requirements, functional specifications, design specifications, test scripts, and validation reports.
    • Conduct risk assessments and formulate risk mitigation strategies.
  2. Automation Expertise:
    • Offer technical guidance in DeltaV systems, ensuring adherence to regulatory standards.
    • Assist in the design, execution, and qualification of automation systems utilized in drug substance production.
    • Diagnose and resolve challenges related to automation systems, ensuring optimal functionality.
  3. Regulatory Compliance:
    • Guarantee that all CSV tasks align with relevant regulations (e.g., FDA, EMA) and industry standards (e.g., GAMP).
    • Perform regular reviews and revalidation of automated systems to uphold compliance.
    • Engage in internal and external audits, supplying validation documentation and evidence as necessary.
  4. Project Management:
    • Oversee and coordinate CSV projects, ensuring timely delivery within budgetary limits.
    • Collaborate with cross-functional teams, including QA, IT, and production, to synchronize validation efforts with project objectives.
    • Track project progress, report on status, and address any issues or discrepancies.
  5. Continuous Improvement:
    • Identify avenues for process enhancements and implement best practices in CSV and automation.
    • Stay informed about the latest advancements in automation technology and regulatory guidelines.
    • Educate and mentor junior engineers and team members on CSV and automation methodologies.
Qualifications:
  • Bachelor's degree in engineering, computer science, or a related discipline.
  • A minimum of 3 years of experience in computer system validation (CSV) within the pharmaceutical sector.
  • Extensive familiarity with DeltaV automation systems.
  • Strong comprehension of regulatory requirements and industry standards (e.g., FDA, EMA, GAMP).
  • Exceptional documentation and technical writing capabilities.
  • Strong analytical skills and attention to detail.
  • Proficiency in project management software and tools.
  • Effective communication and interpersonal abilities.
Expectations:
  • Maintain a high standard of professionalism and dedication to quality and compliance.
  • Exhibit leadership and accountability in all validation endeavors.
  • Encourage a collaborative and positive work atmosphere.
  • Actively seek opportunities for professional development and growth.

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