Validation Engineer – Pharma Equipment – Pharma Solutions

Experience: 3–6 Years
Qualification: Diploma/Degree in Mechatronics or Electrical Engineering
Preferred Experience: Validation / Qualification in Pharma, Pharmaceutical Machinery, FMCG, or Packaging Industry

Role Summary

Manage equipment qualification and validation activities, ensuring customer requirements, qualification protocols, documentation, and regulatory requirements are properly addressed.

Key Responsibilities

• Understand customer qualification requirements and prepare the Qualification Master Plan (QMP).
• Conduct and document Process FMEA (PFMEA).
• Prepare and execute Pre-FAT, FAT, SAT, IQ & OQ protocols.
• Record deviations and coordinate follow-ups.
• Maintain DQ, test documents, and qualification status records.
• Coordinate with customers and project teams on qualification activities.
• Track regulatory changes and incorporate technical changes into FMEA.

Required Skills

• Knowledge of GMP, EMA, FDA and pharmaceutical regulations.
• Understanding of wiring/pneumatic diagrams, HMI, PLC, and sensors.
• Experience with FAT, SAT, IQ, OQ, CSV, VAT, QMP, VMP & Process FMEA.
• Strong communication, documentation, and presentation skills.
• Attention to detail, multitasking ability, and willingness to travel.