2023-907-Validation Engineer-Waterford Contractor

This is a 12-month contract.

Purpose:

The Validation Engineer has a key role in ensuring the ongoing validation compliance of equipment, systems, and processes at Genzyme Ireland in both solid dosage forms and sterile products manufacturing.

Responsibilities:

• Integrally involved in the validation of all new equipment, processes, and control systems at Genzyme Ireland Ltd.
• Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for equipment, process, cleaning, utility, methods, and computerized 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 Genzyme 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 sterilization.
• Ensure that the validation status of equipment and systems is 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 with cGMP at all times.

Requirements:

• 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 GAMP, and 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.
• Good knowledge of quality management systems.
• Effective facilitator.
• Good communication skills at organization, team, and individual levels.
• Ability to use MS Project and SPC packages as an advantage.
• Understands KPIs for the site.