Lab CSV Validation Engineer

3 weeks ago

Cork, Cork, Ireland Process Automation – Controls.Instrumentstions, Inc. 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
  • Please no Agencies
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