Job Title: Engineers - Validation (CSV/PLC)
Experience: 2-4 Years GAMP 5, 21 CFR AND Validation tools like Micro Focus ALM, Validator (Freshers with relevant project knowledge are encouraged to apply)
Key Responsibilities
Validation Management: Execute CSV for software, hardware, and cloud systems per 21 CFR Part 11, GxP, and USFDA standards.
Documentation: Prepare and review Validation Plans, Risk Assessments, IQ/OQ/PQ, and Traceability Matrices.
Compliance: Ensure systems remain audit-ready and maintain strict data integrity.
📋 Site & Compliance Responsibilities
Reporting: Submit daily activity reports and Work Completion Reports (WCR).
Communication: Keep managers informed of site issues and machine availability status.
Client : Obtain client signatures on deliverables and share system backups post-completion.
Logistics: Manage travel bookings and expense claims as per company policy.
Attendance: Maintain daily punch-in/out and manage leave approvals professionally.
Required Skills
Technical: Strong knowledge of USFDA regulations and the validation lifecycle.
Soft Skills: Excellent client coordination and verbal/written communication.
Tools: Proficiency in MS Word is mandatory for technical documentation.
Experience
0 - 4 Years
No. of Openings
10
Education
Graduate (B.Pharma, B.Tech/B.E : Electrical, Electrical and Electronics)
Role
Validation Engineer
Industry Type
Electricals / Switchgears
Gender
Male
Job Country
India
Type of Job
Full Time
Work Location Type
Work from Office