Documentation Engineer – Pharma Solutions

HireLink OÜ; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

HireLink OÜ seeks a Documentation Engineer – Pharma Equipment to manage technical and validation documents for pharmaceutical equipment projects, ensuring compliant documentation and proper version control throughout execution.

The role emphasizes strong technical writing, GMP awareness, and collaboration with Design, Production, QA, and Project teams to support audits and regulatory compliance across the project lifecycle.

Qualifications

• Strong technical writing and documentation skills.
• Knowledge of GMP, validation, and document control practices.
• Proficiency in MS Office and engineering documentation.

Responsibilities

• Prepare DQ, IQ, OQ, PQ, URS, FAT, and SAT documentation.
• Maintain validation records, technical documents, and compliance files.
• Coordinate with Design, Production, QA, and Project teams.
• Ensure document control, version management, and traceability.
• Support customer audits, validation, and regulatory compliance.
• Maintain accurate documentation throughout the project lifecycle.

Skills

Technical writing

GMP knowledge

Document control

MS Office

Coordination

Education

Mechanical Eng.

Job description

Documentation Engineer – Pharma Equipment

Department: Production
Experience: 4+ Years
Qualification: Diploma / Bachelor’s Degree in Mechanical Engineering
Employment Type: Full-Time

Role Summary

Manage technical and validation documentation for pharmaceutical equipment projects by preparing compliant documentation, supporting validation activities, and ensuring document control throughout project execution.

Key Responsibilities

• Prepare DQ, IQ, OQ, PQ, URS, FAT, and SAT documentation.
• Maintain validation records, technical documents, and compliance files.
• Coordinate with Design, Production, QA, and Project teams.
• Ensure document control, version management, and traceability.
• Support customer audits, validation, and regulatory compliance.
• Maintain accurate documentation throughout the project lifecycle.

Required Skills

• Experience in DQ, IQ, OQ, PQ, URS, FAT, and SAT documentation.
• Strong technical writing and documentation skills.
• Knowledge of GMP, validation, and document control practices.
• Proficiency in MS Office and engineering documentation.
• Good coordination, attention to detail, and problem-solving skills.