• CSV Engineer

    Insight Global (Danvers, MA)


    Job Description

    Insight Global is hiring for a CSV Engineer for our medical device client in Danvers, MA. We are seeking a Computer System Validation (CSV) Engineer to ensure that all computer systems and software applications comply with industry standards and regulatory requirements. This role involves collaborating with cross-functional teams, executing validation activities, maintaining documentation, and supporting compliance initiatives.

    Key Responsibilities:

    -Develop and execute remediation activities for CSV processes to assess, plan, and enhance validation practices.

     

    -Create and implement validation plans for new and existing GxP computer systems and digital solutions.

     

    -Lead and/or support SDLC and Software V&V activities, including requirements analysis, validation planning, testing, qualification, and related deliverables.

     

    -Prepare and maintain validation documentation such as test protocols, reports, and risk/compliance assessments.

     

    -Conduct assessments and periodic reviews of validated systems to ensure ongoing compliance with regulatory standards.

     

    -Provide subject matter expertise (SME) in CSV to system owners and users.

     

    Collaborate with QA team members to support quality improvement initiatives.

    Compensation:

    $35/hr to $50/hr.

     

    Exact compensation may vary based on several factors, including skills, experience, and education.

    Employees in this role will enjoy a comprehensive benefits package starting on day one of

    employment, including options for medical, dental, and vision insurance. Eligibility to enroll in

     

    the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this

     

    role will have access to paid sick leave and other paid time off benefits as required under the

     

    applicable law of the worksite location.

     

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

     

    Skills and Requirements

     

    -Bachelor’s degree or equivalent in a relevant field (Computer Science, Engineering, Life Sciences, Data Science, or similar).

     

    -4–6 years of related experience in computer system validation.

     

    -Hands-on experience with CSV in regulated environments such as MedTech or Pharma.

     

    -Strong knowledge of regulatory requirements, including: 21 CFR Part 11 ,EU Annex 11, ISO 13485, IEC 82304, FDA CSA, MDSAP