Current jobs related to CSV Engineer - Raleigh - Salent Solutions

  • Senior IT Engineer 2, CSV Lead

    1 month ago

    Raleigh, North Carolina, United States FUJIFILM Diosynth Biotechnologies Full time

    About This RoleWe are seeking a highly skilled Senior IT Engineer 2, CSV Lead to join our team at FUJIFILM Diosynth Biotechnologies. As a key member of our IT department, you will be responsible for leading Computer System Validation (CSV) efforts and ensuring the highest standards of quality and compliance.Key ResponsibilitiesDevelop and implement CSV plans...

  • Sr Computer System Validation

    2 weeks ago

    raleigh, United States FUJIFILM Diosynth Biotechnologies Full time

    Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real...

  • Sr Computer System Validation

    2 weeks ago

    Raleigh, United States FUJIFILM Diosynth Biotechnologies Full time

    Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real...

  • Sr Computer System Validation

    2 months ago

    Raleigh, United States FUJIFILM Diosynth Biotechnologies Full time

    Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real...

  • Senior Computer System Validation Engineer

    2 months ago

    Raleigh, North Carolina, United States FUJIFILM Diosynth Biotechnologies Full time

    About This RoleThe Senior IT Engineer 2, CSV is a key member of the FUJIFILM Diosynth Biotechnologies team, responsible for leading Computer System Validation (CSV) initiatives. This role requires a strong understanding of GxP Manufacturing and IT Computerized Systems, as well as excellent communication and leadership skills.Key ResponsibilitiesDevelop and...

  • Senior IT Engineer 2

    2 weeks ago

    Raleigh, North Carolina, United States FUJIFILM Diosynth Biotechnologies Full time

    About This RoleThe Senior IT Engineer 2, CSV is a Subject Matter Expert (SME) responsible for leading tasks associated with Computer System Validation (CSV). This role provides input and determines action items on all GxP Manufacturing and IT Computerized Systems, prepares validation documentation, and maintains a validated state with a focus on consistent...

  • Validation Specialist

    2 weeks ago

    Raleigh, North Carolina, United States Valspec Full time

    Job SummaryWe are seeking a highly skilled Validation Specialist to join our team at Valspec. As a key member of our validation team, you will be responsible for ensuring the accuracy and reliability of our computerized systems.Your primary focus will be on developing and executing validation strategies and plans for our Werum PAS-X MES and Fill/Finish...

  • Validation Specialist

    2 weeks ago

    Raleigh, North Carolina, United States Validation & Engineering Group Full time

    Job OverviewValidation & Engineering Group, Inc. is a leading services provider offering solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. We are seeking a talented individual to join our team as a Validation Specialist.Key ResponsibilitiesDevelop and implement validation protocols for process equipment and...

  • Senior Validation Specialist

    6 days ago

    Raleigh, North Carolina, United States Validation & Engineering Group Inc. Full time

    Job Title: Senior Validation SpecialistAbout Us:Validation & Engineering Group, Inc. is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries.Job Summary:We are seeking a talented and dedicated Senior Validation Specialist to join our team. The ideal candidate will have expertise...

  • Data Migration Specialist

    2 weeks ago

    Raleigh, North Carolina, United States Golden Technology Full time

    As a Data Migration Specialist at Golden Technology, you will play a crucial role in helping our clients transition their data systems from on-premises to the cloud. With a focus on Snowflake and Azure, you will work closely with clients to plan and execute a seamless migration, ensuring their data is securely and efficiently moved to the cloud.You will...

CSV Engineer

2 months ago

Raleigh, United States Salent Solutions Full time $60 - $115
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.

Powered by JazzHR

clXuVIpiV1