Lab Validation Engineer

Role Summary:

• A new opportunity has arisen for a Lab Validation Engineer based on our client’s busy pharmaceutical site in Co. Waterford.
• The Validation Engineer has a key role in ensuring the on-going validation compliance of equipment, systems and processes on site in both solid dosage forms and sterile products manufacturing.

Core Duties and Responsibilities:

• Integrally involved in the validation of all new equipment, processes and control systems on site.
• Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for equipment, process, cleaning, utility, methods, 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 site 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.

Minimum Qualifications and 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
• 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
• Able to execute projects to plan.

Please note, we do not require agency assistance with this role.