CSV Engineer

About the role

Job Description

Insight Global is hiring a CSV Engineer for our medical device client based in Danvers, MA. This role will be fully remote and offshore in India. We are seeking a Computer System Validation (CSV) Engineer to support the validation and ongoing compliance of computerized systems and software applications within a regulated environment.

This individual will collaborate with cross-functional teams to execute validation activities, maintain validation documentation, review and approve testing, and support compliance initiatives. The CSV Engineer will also utilize Jira to track user requirements, testing activities, and review requirements associated with software changes. The ideal candidate will be comfortable working independently in an offshore environment while maintaining consistent overlap with the U.S.-based team.

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. -Use Jira to track and manage user requirements, testing activities, reviews, and documentation associated with software changes. -Review test scripts created by project team members and provide feedback and/or approval of completed testing. -Support equipment software validation activities, maintaining appropriate traceability between requirements, testing, and validation documentation. -Prepare and maintain validation documentation, including test protocols, reports, and risk/compliance assessments. -Conduct assessments and periodic reviews of validated systems to support ongoing compliance with regulatory requirements. -Provide CSV subject matter expertise to system owners and users. -Collaborate with QA and cross-functional stakeholders to support quality and continuous improvement initiatives. -Work independently and effectively within an offshore delivery model while coordinating with U.S.-based stakeholders. -Must be able to work through 5:00 PM EST to provide consistent overlap with the U.S.-based team.

Skills and Requirements

-Bachelor’s degree or equivalent in Computer Science, Engineering, Life Sciences, Data Science, or a related field is preferable -4–6 years of experience in computer system validation. -Hands-on experience with CSV in a regulated MedTech, pharmaceutical, or life sciences environment. -Experience using Jira for requirements tracking, testing, software change management, and/or validation activities. -Experience reviewing and approving test scripts and associated testing documentation. -Working knowledge of Salesforce is preferred. -Deep Salesforce expertise is not required, but candidates should understand the platform and how it is used within a business/system environment. -Strong knowledge of applicable regulatory requirements and standards, including 21 CFR Part 11, EU Annex 11, ISO 13485, IEC 82304, FDA CSA, and MDSAP. -Ability to work independently and communicate effectively with cross-functional and U.S.-based teams. -Ability to consistently work through 5:00 PM EST is required.

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 employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to 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 the recruiting process, please send a request to [email protected].

Posting text as published by Insight Global.

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Location as listed

Danvers, MA

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