Job Title: Plant Engineering Specialist
We are seeking a skilled Plant Engineering Specialist to join our team for a contract duration of 12-24 months.
1. This is an opportunity for experienced equipment installation, qualification, and validation professionals to showcase their skills in manufacturing/packaging lines.
2. The successful candidate will lead engineering projects covering equipment installation, commissioning, and qualification of pharmaceutical production and utility systems.
3. The key responsibility includes ensuring all activities are conducted in compliance with cGMP, FDA, HPRA, and internal quality and safety standards.
4. The Plant Engineering Specialist will support process equipment troubleshooting, calibration, and preventive maintenance to maintain optimal uptime and product quality.
5. Detailed technical documentation including User Requirement Specifications, Design Specifications, and Validation Protocols must be authored and reviewed by the specialist.
6. The role involves managing change control processes for new and modified equipment, ensuring full traceability and regulatory compliance.
7. The specialist will apply risk management principles to identify, evaluate, and mitigate potential equipment failures.
8. Ongoing equipment-related continuous improvement initiatives must be driven by the specialist to increase process reliability, reduce downtime, and enhance efficiency.
9. External contractors and service providers must be overseen during installation, commissioning, and maintenance phases by the Plant Engineering Specialist.
10. The specialist will act as Subject Matter Expert during internal and external regulatory audits, demonstrating equipment compliance and validation status.
11. Cross-functional collaboration with Quality, Validation, Manufacturing, and Maintenance teams is essential to ensure seamless project execution and equipment integration.
12. The specialist may provide out-of-hours engineering support when required to maintain production continuity and meet project deadlines.