Validation Engineer

Website TPM04145

Summary:
Our client is a global biologics 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 in both solid dosage forms and sterile products manufacturing.

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, and computerised systems.
  • Participates in the change control process advising on validation issues, as appropriate Compliance Related Tasks.
  • Hands on role in the development and execution of DQ, IQ, OQ and PQ activities.
  • Ensures projects are managed in compliance with all required company 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.
  • 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.
  • Ability to use MS Project and SPC packages an advantage.

To apply for this job email your details to orla.daly@tandempm.ie.