CSV Engineer (INTRL - India)

Insight Global is hiring for a CSV Engineer for our medical device client in Danvers, MA. This role will sit fully remote and offshore in India. 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. Hours will be roughly 12-8pm IST daily, based on project needs., 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.

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

$30-35/hr.

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