About the Role:
We are seeking a seasoned Computer System Validation (CSV) and Regulatory Compliance Specialist with a strong background in GxP, GAMP 5, and 21 CFR Part 11 to lead and support the validation of our technology platforms, applications, and services. This individual will work closely with cross-functional teams to ensure that all systems impacting regulated data or processes are validated and maintained in accordance with applicable industry and regulatory standards.
Key Responsibilities:
Required Qualifications:
Minimum 10 years of experience in CSV within regulated industries (life sciences, healthcare, pharma, etc.) Deep understanding of GxP, GAMP 5, 21 CFR Part 11, and data integrity principles Demonstrated experience validating a variety of systems (e.g., LIMS, ERP, eQMS, cloud platforms, SaaS) Strong technical writing skills and attention to detail for documentation Experience supporting audits by FDA, EMA, or other regulatory bodies Ability to lead validation projects independently from planning through execution and closure Familiarity with change control, CAPA, and deviation management in regulated environments Excellent communication, collaboration, and project management skills
Preferred Qualifications:
Certifications in CSV, GAMP 5, or related regulatory compliance programs Bachelor’s or Master’s degree in Computer Science, Life Sciences, Engineering, or related field Experience working in Agile/DevOps environments while ensuring compliance Familiarity with cloud platforms (e.g., AWS, Azure) and their validation in a regulated context
Job details are sourced from the employer's original posting.
Open job postingAbout the company
For over 20 years, TransPerfect has provided comprehensive language and technology solutions to help our clients communicate and conduct business more effectively in a global marketplace. Equipped with a quality management system certified to both the ISO 9001:2008 and EN 15038:2006 standards, TransPerfect provides a full array of language and business support services, including translation, interpretation, multicultural marketing, website globalization, subtitling, voiceovers, staffing services, multicultural marketing, training and learning, and legal support services. TransPerfect also offers a suite of cutting edge technologies that significantly reduce costs and improve consistency throughout the translation process, making TransPerfect the vendor of choice for the world's leading multinationals. With annual revenues of over $470 million, TransPerfect is the world's largest privately held provider of language services and technology solutions. From offices in more than 85 cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and EN 15038 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong. TransPerfect offers a comprehensive benefits package including: medical, dental, vision, 401k, paid time-off, company sponsored life insurance, short term and long term disability, flexible spending account options, and a pro-active and accessible HR department that focuses on the staff's health and happiness.