Lab CSV Validation Engineer - must have valid EU Work Permit and Irish Residency
PACIV IRE - cork, Cork, Ireland - Full Time
PACIV required a Lab CSV Engineer for a multinational pharmaceutical client site in Leinster. The role requires a presence at site 5 days per week.
Duties and Responsibilities:
The Validation Engineer will write and execute validation protocols, such as Installation, Operational, and Performance Qualifications (IOPQs).
Will be responsible to plan, manage, and execute the start-up, commissioning, and validation of new equipment. Primary focus shall be in the lab equipment delivery & qualification.
They will provide support and troubleshooting to manufacturing operations as well as identify process improvements and capacity constraints and design and execute projects to support corporate goals.
Projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards.
Investigate process and quality problems and implement corrective actions.
Identify and define project and process improvement opportunities.
Develop project plans and timelines.
Track project goals.
Follow Biotech/Pharmaceutical industry standards in generating and updating supporting documentation such as P&IDs, material and equipment specifications, and requirement specifications.
Work within cross functional teams.
Communicate progress effectively.
Ensure process and project documentation is accurate and updated.
Maintain safe working environment.
Follow company policies and procedures.
Willingness to learn new technologies and platforms.
Open to collaborating in a team setting.
Requirements
Degree/ Diploma in Science field required but Mechanical Engineering or Chemical Engineering is preferred.
5+ years’ experience with Lab Equipment such as PH & Conducitivity Meters, Air Samplers and Particle Counters, Balances, Analysers & Washers.
Familiar with IT systems and applications commonly deployed on windows based equipment
Must have a valid EU Work Permit and Irish Residency