Validation Engineer – Pharma Equipment – Pharma Solutions

HireLink; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

HireLink in Bengaluru seeks a Validation Engineer to manage equipment qualification and validation activities for pharma solutions. You will ensure customer requirements, protocols, documentation, and regulatory compliance are met.

The role requires 3–6 years in Mechatronics or Electrical Engineering with GMP/EMA/FDA knowledge, CSV, and experience with FAT/IQ/OQ. Travel may be required.

Qualifications

• 3–6 years of experience in validation or qualification in pharma equipment.
• Bachelor’s/Diploma in Mechatronics or Electrical Engineering required.
• Knowledge of GMP/EMA/FDA regulations and CSV practices.

Responsibilities

• Understand customer qualification requirements and prepare the Qualification Master Plan (QMP).
• Conduct and document 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.

Skills

GMP/ EMA/ FDA knowledge

Strong communication

Willingness to travel

Education

Diploma/Degree in Mechatronics or Electrical Engineering

Tools

PLC & HMI

Sensors

Wiring diagrams

Job description

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.