Job Overview
A Pharmaceutical Equipment Specialist is needed to lead equipment engineering projects covering installation, commissioning, and qualification (IQ/OQ/PQ) of pharmaceutical production and utility systems.
About the Role
* Led equipment engineering projects covering installation, commissioning, and qualification (IQ/OQ/PQ) of pharmaceutical production and utility systems ensuring compliance with cGMP, FDA, HPRA, and internal quality and safety standards.
* Oversaw process equipment troubleshooting, calibration, and preventive maintenance to maintain optimal uptime and product quality.
* Authored and reviewed technical documentation including User Requirement Specifications (URS), Design Specifications (DS), and Validation Protocols.
* Managed change control processes for new and modified equipment ensuring full traceability and regulatory compliance.
* Applied risk management principles (FMEA, risk assessments) to identify, evaluate, and mitigate potential equipment failures.
* Ensured seamless project execution and equipment integration through collaboration with Quality, Validation, Manufacturing, and Maintenance teams.
Key Qualifications
* Proven experience in equipment installation, qualification, and validation of manufacturing/packaging lines.
* Familiarity with process equipment and regulatory requirements.
* Excellent communication and teamwork skills.
We Offer
A rewarding opportunity to work on challenging equipment engineering projects and contribute to the success of our organization.
Contact Us
To learn more about this exciting opportunity, please get in touch with us.