Job Title: Equipment Engineer
We are seeking a highly skilled Equipment Engineer to join our team on a 12-24 month contract. The successful candidate will be responsible for the installation, qualification, and validation of manufacturing/packaging lines.
Key Responsibilities:
1. Led equipment engineering projects covering installation, commissioning, and qualification (IQ/OQ/PQ) of pharmaceutical production and utility systems.
2. Ensured all activities were conducted in compliance with cGMP, FDA, HPRA, and internal quality and safety standards.
3. Supported process equipment troubleshooting, calibration, and preventive maintenance to maintain optimal uptime and product quality.
4. Authored and reviewed technical documentation including User Requirement Specifications (URS), Design Specifications (DS), and Validation Protocols.
5. Managed change control processes for new and modified equipment, ensuring full traceability and regulatory compliance.
6. Applied risk management principles (FMEA, risk assessments) to identify, evaluate, and mitigate potential equipment failures.
7. Drove equipment-related continuous improvement initiatives to increase process reliability, reduce downtime, and enhance efficiency.
8. Oversaw external contractors and service providers during installation, commissioning, and maintenance phases.
9. Acted as Subject Matter Expert (SME) during internal and external regulatory audits, demonstrating equipment compliance and validation status.
10. Collaborated cross-functionally with Quality, Validation, Manufacturing, and Maintenance teams to ensure seamless project execution and equipment integration.
11. Provided out-of-hours engineering support when required to maintain production continuity and meet project deadlines.
Requirements:
* Bachelor's Degree in Engineering or related discipline.
* Project Management Certification (e.g., PMP, PRINCE2).
* Experience on process automation equipment essential.
* Knowledge of Automation and Control Systems (SCADA, PLCs).