CSV Engineer

1 month ago

Raleigh, United States Salent Solutions Full time
Job DescriptionJob Description

CSV Engineer - Automation

Location: Raleigh, NC

Company: Salent Solutions 

Compensation: Commensurate with Experience 

About this opportunity: 

Salent Solutions provides commissioning, qualification, and validation services to the biotech and pharmaceutical industries. We are passionate about providing quality service to companies that provide life-saving drugs. If you’re looking to work on the latest life sciences projects then this is the role for you

We are seeking a highly motivated and experienced CSV Engineer specializing in automation with a strong background in DeltaV systems. The successful candidate will be responsible for ensuring that our automated systems meet regulatory requirements and industry standards through comprehensive computer system validation processes.

Key Responsibilities:

  1. CSV Activities:

    • Plan, develop, and execute computer system validation (CSV) protocols and activities for automated systems, particularly DeltaV.
    • Create and review validation documentation, including user requirements, functional specifications, design specifications, test scripts, and validation reports.
    • Perform risk assessments and develop risk mitigation strategies.

  2. Automation Expertise:

    • Provide technical expertise in DeltaV systems, ensuring compliance with regulatory requirements.
    • Support the design, implementation, and qualification of automation systems used in drug substance manufacturing.
    • Troubleshoot and resolve issues related to automation systems and ensure their optimal performance.

  3. Regulatory Compliance:

    • Ensure all CSV activities comply with applicable regulations (e.g., FDA, EMA) and industry standards (e.g., GAMP).
    • Conduct periodic reviews and revalidation of automated systems to maintain compliance.
    • Participate in internal and external audits, providing validation documentation and evidence as required.

  4. Project Management:

    • Manage and coordinate CSV projects, ensuring timely completion within budget constraints.
    • Collaborate with cross-functional teams, including QA, IT, and production, to align validation activities with project goals.
    • Monitor project progress, report on status, and address any issues or deviations.

  5. Continuous Improvement:

    • Identify opportunities for process improvements and implement best practices in CSV and automation.
    • Stay updated with the latest advancements in automation technology and regulatory requirements.
    • Train and mentor junior engineers and team members on CSV and automation practices.

Qualifications:

  • Bachelor’s degree in engineering, computer science, or a related field.
  • Minimum of 3 years of experience in computer system validation (CSV) within the pharmaceutical industry.
  • Extensive experience with DeltaV automation systems.
  • Strong understanding of regulatory requirements and industry standards (e.g., FDA, EMA, GAMP).
  • Excellent documentation and technical writing skills.
  • Strong problem-solving abilities and attention to detail.
  • Proficiency in project management software and tools.
  • Effective communication and interpersonal skills.

Expectations:

  • Maintain a high level of professionalism and commitment to quality and compliance.
  • Demonstrate leadership and accountability in all validation activities.
  • Foster a collaborative and positive work environment.
  • Proactively seek opportunities for professional growth and development.

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