Lab CSV Validation Engineer - must have valid EU Work Permit and Irish Residency
PACIV
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
+ Please no Agencies
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