- Expertini Resume Scoring: See how well your CV/Résumé matches this job: IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581).
Urgent! IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581) in Gurugram, India | Source-Right Inc. | Expertini
Position: IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581)
Job Summary:
The Computer System Validation (CSV) Engineer is responsible for ensuring that computerized systems used in regulated environments (e.g., GMP, GCP, GLP) are validated in compliance with applicable regulatory requirements such as 21 CFR Part 11, Annex 11, GAMP 5.
This role involves planning, authoring, reviewing, and executing validation deliverables, and supporting cross-functional teams.
Key Responsibilities:
Develop and execute validation strategies and plans for new and existing computerized systems.
Create and maintain validation documents including:
Ø User Requirements Specifications (URS)
Ø Functional Specifications (FS)
Ø Risk Assessments
Ø Validation Plans (VP)
Ø IQ/OQ/PQ Protocols and Reports
Ø Traceability Matrix
Ensure compliance with FDA regulations, EMA guidelines, and GAMP 5 standards.
Collaborate with IT, Quality Assurance, Manufacturing, and other stakeholders to ensure system functionality meets business and regulatory needs.
Perform impact assessments and change control activities for validated systems.
Support data integrity initiatives and ensure systems comply with 21 CFR Part 11 requirements.
Provide training and guidance on CSV processes and best practices.
Maintain validation documentation in alignment with company procedures and regulatory expectations.
Requirement Education:
Bachelor's degree in engineering, Computer Science, Life Sciences, or related field.
Experience:
2–5+ years of experience in CSV within regulated industries (pharma, biotech, medical devices).
Experience with validating systems such as LIMS, MES, ERP, QMS, SCADA, PLCs, and custom applications.
Skills & Knowledge:
Strong knowledge of GAMP 5, 21 CFR Part 11, Annex 11.
Understanding of software development life cycle (SDLC) and risk-based validation approaches.
Excellent documentation, communication, and project management skills.
Familiarity with electronic recordkeeping and audit trail requirements.
Proficient in MS Office and validation software tools (e.g., ValGenesis, MasterControl) is a plus.
Preferred Qualifications:
CSV certifications (e.g., ISPE, PDA) or GxP training.
Experience in data integrity assessments and remediation projects.
Familiarity with cloud-based systems and cybersecurity considerations.
Working Conditions:
On-site or hybrid depending on organization.
*******************************************************************************************************************************************
Job Category: Others
Job Type: Full Time
Job Location: Gurgaon
Experience: 2 - 5 Years
Notice period: 0-15 days
✨ Smart • Intelligent • Private • Secure
Practice for Any Interview Q&A (AI Enabled)
Predict interview Q&A (AI Supported)
Mock interview trainer (AI Supported)
Ace behavioral interviews (AI Powered)
Record interview questions (Confidential)
Master your interviews
Track your answers (Confidential)
Schedule your applications (Confidential)
Create perfect cover letters (AI Supported)
Analyze your resume (NLP Supported)
ATS compatibility check (AI Supported)
Optimize your applications (AI Supported)
O*NET Supported
O*NET Supported
O*NET Supported
O*NET Supported
O*NET Supported
European Union Recommended
Institution Recommended
Institution Recommended
Researcher Recommended
IT Savvy Recommended
Trades Recommended
O*NET Supported
Artist Recommended
Researchers Recommended
Create your account
Access your account
Create your professional profile
Preview your profile
Your saved opportunities
Reviews you've given
Companies you follow
Discover employers
O*NET Supported
Common questions answered
Help for job seekers
How matching works
Customized job suggestions
Fast application process
Manage alert settings
Understanding alerts
How we match resumes
Professional branding guide
Increase your visibility
Get verified status
Learn about our AI
How ATS ranks you
AI-powered matching
Join thousands of professionals who've advanced their careers with our platform
Unlock Your IA Computer Potential: Insight & Career Growth Guide
Real-time IA Computer Jobs Trends in Gurugram, India (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for IA Computer in Gurugram, India using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 2166 jobs in India and 41 jobs in Gurugram. This comprehensive analysis highlights market share and opportunities for professionals in IA Computer roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Source-Right Inc. is currently hiring and seeking a IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581) to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581) Jobs Gurugram.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Source-Right Inc. adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581) Jobs India varies, but the pay scale is rated "Standard" in Gurugram. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581) typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
To improve your chances of getting hired for IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581), consider enhancing your skills. Check your CV/Résumé Score with our free Resume Scoring Tool. We have an in-built Resume Scoring tool that gives you the matching score for each job based on your CV/Résumé once it is uploaded. This can help you align your CV/Résumé according to the job requirements and enhance your skills if needed.
Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581) interview at Source-Right Inc., research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Source-Right Inc.'s products or services and be prepared to discuss how you can contribute to their success.
By following these tips, you can increase your chances of making a positive impression and landing the job!
Setting up job alerts for IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581) is easy with India Jobs Expertini. Simply visit our job alerts page here, enter your preferred job title and location, and choose how often you want to receive notifications. You'll get the latest job openings sent directly to your email for FREE!