IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581)

5 years

0 Lacs

gurgaon haryana india

Posted:3 days ago| Platform: Linkedin logo

Apply

Skills Required

gcp compliance planning strategies risk reports traceability regulations manufacturing support data integrity training documentation engineering lims erp scada plcs software development communication management recordkeeping audit mastercontrol certifications remediation cybersecurity

Work Mode

On-site

Job Type

Full Time

Job Description

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.

  • More Jobs at Source-Right

    Absli (versant 4) Renewal (TC0FF RM 3375)

    thane, maharashtra, india

    Experience: Not specified

    |

    Salary: Not disclosed

    BOI (versant 3) remainder calling / Inbound (TC0FF RM 3381)

    thane, maharashtra, india

    Experience: Not specified

    |

    Salary: Not disclosed

    Customer Support Executive – LIC Process (TC00FF RM 3516)

    thane, maharashtra, india

    Experience: Not specified

    |

    Salary: Not disclosed

    IDFC Cross-Selling Associate (versant3/4) (TC0FF RM 3373)

    thane, maharashtra, india

    Experience: Not specified

    |

    Salary: Not disclosed

    Yes Bank sales (versant 3) (TC0FF RM 3377)

    thane, maharashtra, india

    Experience: Not specified

    |

    Salary: Not disclosed

    Mock Interview

    Practice Video Interview with JobPe AI

    Start Job-Specific Interview
    cta

    Start Your Job Search Today

    Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

    Job Application AI Bot

    Job Application AI Bot

    Apply to 20+ Portals in one click

    Download Now

    Download the Mobile App

    Instantly access job listings, apply easily, and track applications.

    Google Play App Store
    coding practice

    Enhance Your Skills

    Practice coding challenges to boost your skills

    Start Practicing Now
    Source-Right

    RecommendedJobs for You

    IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581)

    Source-Right

    gurgaon, haryana, india

    Source-right logo

    IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581)

    Source-right

    gurgaon

    IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581)

    Source-Right

    gurgaon, haryana, india

    Source-right logo

    IA – Computer System Validation (CSV) Engineer (CE25SF RM 3581)

    Source-right

    gurgaon