Qualification Engineer

Job Summary

We are seeking a meticulous and proactive Qualification Engineer to ensure that all processes and equipment within the facility operate safely, efficiently, and in compliance with internal standards and regulatory requirements. This role will focus heavily on evaluating new or existing processes, identifying risks, proposing improvement solutions, and performing qualification activities for new/change equipment and process.

Key Responsibilities

1. Process Evaluation & Improvement

For new processes, ongoing processes, or processes requiring change, the Qualification Engineer will:

• Conduct risk assessments to identify potential process failures or quality concerns by FMEA method
• Work with cross‑functional teams (QC, Production, Engineering, etc.) to discuss risks, define improvement solutions, and identify root causes.
• Implement corrective and preventive actions and ensure follow‑up until closure.
• Document findings, create structured reports, and maintain compliance with GMP/ISO standards.

2. Qualification & Assessment of New Equipment

• Lead equipment qualification activities (IQ/OQ/PQ) for newly installed machinery.
• Review and verify equipment technical specifications to ensure suitability for intended use.
• Coordinate with testing, engineering teams, and internal stakeholders during equipment installation, testing, validation, and handover.
• Ensure all qualification documentation, including protocols and reports, meets internal and regulatory requirements.

3. Compliance & Documentation

• Ensure all activities comply with GMP, ISO, safety standards, and company SOPs.
• Maintain accurate and complete qualification files, validation documents, and technical records.
• Assist in internal and external audits by providing necessary technical documentation and explanations.

4. Cross‑Functional Collaboration

• Work closely with Production, Engineering, QC, Planning teams to ensure seamless process and equipment readiness.
• Provide technical support during process changes, deviation investigations, and improvement discussions.

5. Other Responsibilities

• Support calibration, change control, and deviation investigations where technical analysis is required.
• Participate in training sessions and contribute to building best practices for qualification and process evaluation activities.
• Perform additional tasks as assigned by the manager.

Qualifications

• Bachelor’s degree in Engineering, Pharmacy, Mechanical Engineering, Chemical Engineering, or related field.
• Experience in risk assessment, equipment qualification, process validation, or quality/engineering in a regulated environment is preferred.
• Strong analytical.
• Ability to work independently and manage multiple tasks simultaneously.
• Good communication skills and ability to collaborate effectively with cross‑functional teams.
• Familiarity with GMP, ISO, or similar quality standards is an advantage.