Job Description
Role Description
This is a full-time on-site role for a CSV (Computer System Validation) Engineer located in Pune. The CSV Engineer will be responsible for planning, executing, and maintaining validation processes for computer systems to ensure compliance with regulatory and industry standards. Daily responsibilities include drafting and reviewing validation documentation such as protocols and reports, performing risk assessments, and collaborating with cross-functional teams to ensure validated systems are fit for purpose. The role also involves troubleshooting issues, providing technical guidance, and ensuring that all validation activities are completed on time and within scope.
Qualifications
• Experience in Computer System Validation (CSV) processes and techniques
• Strong knowledge of regulatory compliance requirements such as FDA, GxP, and 21 CFR Part 11
• Proficiency in drafting validation documentation, including protocols, risk assessments, and validation reports
• Solid understanding of IT systems, software development life cycle (SDLC), and quality assurance processes
• Excellent analytical, organizational, and problem-solving skills
• Strong communication and collaboration skills, with the ability to interact with cross-functional teams
• Bachelor’s degree in Computer Science, Engineering, or a related field
• Experience in the pharmaceutical or life sciences industry is a plus 1-3 years
This is a full-time on-site role for a CSV (Computer System Validation) Engineer located in Pune. The CSV Engineer will be responsible for planning, executing, and maintaining validation processes for computer systems to ensure compliance with regulatory and industry standards. Daily responsibilities include drafting and reviewing validation documentation such as protocols and reports, performing risk assessments, and collaborating with cross-functional teams to ensure validated systems are fit for purpose. The role also involves troubleshooting issues, providing technical guidance, and ensuring that all validation activities are completed on time and within scope.
Qualifications
• Experience in Computer System Validation (CSV) processes and techniques
• Strong knowledge of regulatory compliance requirements such as FDA, GxP, and 21 CFR Part 11
• Proficiency in drafting validation documentation, including protocols, risk assessments, and validation reports
• Solid understanding of IT systems, software development life cycle (SDLC), and quality assurance processes
• Excellent analytical, organizational, and problem-solving skills
• Strong communication and collaboration skills, with the ability to interact with cross-functional teams
• Bachelor’s degree in Computer Science, Engineering, or a related field
• Experience in the pharmaceutical or life sciences industry is a plus 1-3 years
💡 Quick Summary
Seeking a career-building opportunity? The CSV Engineer position is now open for candidates interested in the Software Developer Jobs sector. This role in Pune offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Software Developer Jobs is a plus.