Job Summary:
PACIV seeks a skilled Lab CSV Engineer to support a multinational pharmaceutical client site in Leinster, Ireland. This role requires on-site presence for five days a week.
Duties and Responsibilities:
* Develop and execute validation protocols, including Installation, Operational, and Performance Qualifications (IOPQs).
* Plan, manage, and execute the start-up, commissioning, and validation of new equipment, focusing on lab equipment delivery and qualification.
* Provide technical support and troubleshooting to manufacturing operations, identify process improvements and capacity constraints, and design and execute projects to align with corporate goals.
* Ensure all projects and duties are completed in accordance with applicable cGMP, FDA, and regulatory agency standards.
* Investigate process and quality issues, implement corrective actions, and identify opportunities for project and process improvement.
* Develop project plans, timelines, and track progress against goals.
* Maintain accurate and up-to-date process and project documentation.
* Ensure a safe working environment and adhere to company policies and procedures.
Requirements:
* Bachelor's degree or diploma in a science-related field; Mechanical Engineering or Chemical Engineering is preferred.
* At least five years' experience with lab equipment, including PH & Conducitivity Meters, Air Samplers, Particle Counters, Balances, Analysers, and Washers.
* Familiarity with IT systems and applications commonly deployed on Windows-based equipment.
* Valid EU Work Permit and Irish Residency.