Validation Engineer

Summary:
Our client is a global biopharmaceutical company based in Waterford, looking for a Validation Engineer who will play a key role in ensuring the ongoing validation compliance of equipment, systems and processes.

Responsibilities:

• Integrally involved in the validation of all new equipment, processes and control systems.
• Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for equipment, process, cleaning, utility, methods, laboratory equipment, and computerised systems.
• Participates in the change control process advising on validation issues, as appropriate.
• Hands on role in the development and execution of DQ, IQ, OQ and PQ activities.
• Ensures projects are managed in compliance with all required and legal requirements (Health & Safety, cGMP, construction, environmental etc).
• Designs, implements and executes validation studies for manufacturing and control equipment.
• Additional responsibilities for critical systems and facilities as well as validation studies to satisfy regulatory compliance.
• Provide technical assistance on current US FDA and EU validation requirements for solid dose manufacture and lyophilization, aseptic processing and sterilisation.
• Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
• Maintain validation documentation through the approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans.
• Generate/review/approve execution of the validation/revalidation plans.
• Review and approval of site change controls.
• Ensure compliance to cGMP at all times.

Qualifications & Experience:

• Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec).
• Post-graduate studies as appropriate to augment primary Degree.
• 3-5 years’ experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
• 2-3 years’ experience in validation environment.
• Experience in qualification of laboratory equipment.
• Project management experience.
• Capable of troubleshooting validation issues associated with projects, process development etc.
• Competent technical knowledge of pharmaceutical plants.
• Knowledge of requirements for of GAMP, ISPE Baseline guides.
• Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.
• Full understanding of relevant quality and compliance regulations.
• Ability to use MS Project and SPC packages an advantage.
• Understands KPI’s for the site.