Csv Engineer

Vaisesika Consulting

6 - 11 years

20 - 25 Lacs

bengaluru

Posted:3 weeks ago| Platform:

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Skills Required

csv computer system validation 21 cfr gxp

Work Mode

Remote

Job Type

Full Time

Job Description

Job Title:

Key Responsibilities

Lead and execute end-to-end computer system validation activities in alignment with organizational and regulatory standards.
Author, review, and approve validation deliverables including URS, FRS, RTM, IQ/OQ/PQ protocols, summary reports, and validation plans.
Ensure compliance with regulatory guidelines such as
FDA 21 CFR Part 11
,
EU Annex 11
,
GAMP 5
, and internal quality procedures.
Manage and support
change control processes
, including impact assessments and validation impact evaluations.
Conduct risk assessments, validation planning, assurance activities, and reporting.
Collaborate with QA, IT, Business, and vendor teams to ensure smooth execution of validation tasks.
Provide oversight and subject matter expertise during system qualification and audit readiness.
Work independently and manage CSV activities across multiple systems simultaneously.

Required Skills & Qualifications

5+ years
of hands-on experience in
CSV within the Life Sciences / Pharma domain
.
Strong understanding of regulatory requirements:

FDA 21 CFR Part 11
EU Annex 11
GAMP 5

Proven expertise in the validation lifecycle, documentation, and industry best practices.
Proficiency in authoring, reviewing, and managing validation deliverables.
Strong knowledge of
change control management
processes.
Experience in qualification protocol development and review.
Excellent communication skills both verbal and written.
Ability to work independently and in cross-functional environments, managing multiple priorities.

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