Validation Engineer

Qualify IT Solutions; Hyderabad; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Qualify IT Solutions is seeking a pharma validation specialist to ensure CSV, CQV readiness, and adherence to US FDA, EU GMP, WHO guidelines. You will plan, execute, and document validation activities across facilities, equipment, systems and utilities.

The role requires a engineering or life sciences degree and 2–5 years of GMP validation experience, with strong analytical, data integrity, and documentation skills. Proficiency in ALCOA++ and QMS software is beneficial.

Qualifications

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

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 audits.

Skills

Strong analytical skills

Problem-solving

Documentation skills

MS Office proficiency

QMS software familiarity

Written and verbal communication

Education

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

Job description

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.

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.

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 …

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.