Equipment Engineer
About the Role:
We are seeking an experienced Equipment Engineer to join our team. The successful candidate will be responsible for leading equipment engineering projects, ensuring compliance with regulatory standards and quality requirements.
This is a contract role with a duration of 12-24 months.
* Led equipment engineering projects covering installation, commissioning, and qualification (IQ/OQ/PQ) of pharmaceutical production and utility systems.
* Maintained compliance with cGMP, FDA, HPRA, and internal quality and safety standards through meticulous planning and execution.
* Supported process equipment troubleshooting, calibration, and preventive maintenance to ensure 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, guaranteeing full traceability and regulatory compliance.
* Applied risk management principles (FMEA, risk assessments) to identify, evaluate, and mitigate potential equipment failures.
* Driven continuous improvement initiatives to enhance process reliability, reduce downtime, and boost efficiency.
* Oversaw external contractors and service providers during installation, commissioning, and maintenance phases.
* Served as Subject Matter Expert (SME) during internal and external regulatory audits, demonstrating equipment compliance and validation status.
* Collaborated with cross-functional teams to ensure seamless project execution and equipment integration.
* Provided out-of-hours engineering support when required to maintain production continuity and meet project deadlines.