We are seeking a hands-on engineer with strong technical expertise, practical troubleshooting skills, and the ability to engage in technical discussions. This is not a laboratory or bench-top role.
Qualifications:
Bachelor's degree in Engineering (Mechanical, Chemical, or related fields).
Industry experience in pharmaceuticals, chemicals, oil refineries, or mechanical systems.
Expertise in manufacturing equipment reliability, troubleshooting, and cGMP compliance.
Role Overview:
This position supports manufacturing activities for cGMP equipment and facilities. The Senior Engineer collaborates across teams to ensure equipment reliability, operational excellence, and compliance with safety and quality standards while driving capital projects and strategic initiatives.
Key Responsibilities:
Ensure manufacturing equipment reliability and deliverables for key capital projects.
Identify critical quality parameters and propose risk-based design improvements.
Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).
Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards..
Act as a liaison between engineering and quality assurance during project phases.
Review commissioning reports, maintenance practices, and drive productivity enhancements.