Lab CSV Validation Engineer
3 weeks ago
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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