CSV & CQV

Validation Engineer

Execute validation activities and maintain Quality Management Systems across pharmaceutical service offerings. Ensure that all operations meet the highest standards of quality, regulatory compliance, and internal policies.

Location

Hyderabad, India (Onsite)

Type

Full-time · 55 hrs / week

Level

Mid-Level

Experience

2–5 years

About the role

Responsibilities

Prepare, review and execute CSV and CQV documents including Validation Master Plan, SLIA and GAP Assessment.

Author engineering studies — URS, DQ, FAT, SAT, IQ, OQ and PQ protocols and reports for facilities, equipment, systems and utilities.

Manage document protocol, equipment/instrument, change control and deviation numbering; maintain validation data archival and instrument moment register.

Develop and maintain the Validation Master Plan (VMP); plan annual and project-specific validation schedules based on risk assessment.

Coordinate validation strategies across QA, Engineering, Production and IT for on-time protocol execution.

Analyze test results, perform data integrity checks, ensure traceability, and troubleshoot deviations during execution.

Ensure compliance with US FDA, EU GMP, WHO, PIC/S, ICH, ASTM E2500, GAMP 5 and 21 CFR Part 11.

Evaluate change impact via risk assessments, participate in change control boards, and lead deviation investigations and CAPAs.

Requirements

Bachelor's degree in Engineering, Life Sciences, Chemistry or related discipline.

2–5 years of professional experience in pharmaceutical validation, quality assurance or GMP operations.

Working knowledge of CSV, CQV, IQ/OQ/PQ and GAMP 5 methodologies.

Understanding of FDA, EMA, ICH, WHO guidelines and regulatory requirements.

Strong analytical, problem-solving and documentation skills aligned with ALCOA++ principles.

Excellent written and verbal communication; proficiency in MS Office and QMS software.

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