Validation Specialist

Morgan McKinley is partnering with a leading Dublin based Pharmaceutical manufacturer who is seeking a Validation Specialist for a 6 month hourly rate contract.

The Role;

• To ensure qualification and validation of equipment, facilities, utilities, automated systems, processes and process cleaning procedures are carried out in accordance with site procedures and policies, cGMP and relevant guidelines.
• Review and approval of third party generated protocols and reports.
• Preparation, review and approval of qualification and/or validation documentation (specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes.
• Review, execution and approval of factory acceptance testing.
• Review, execution and approval of site acceptance testing (commissioning) activities.
• Preparation, review and approval of the site validation master plan.
• Evaluation of equipment suppliers/vendors.
• Participate in change control activities.

Required;

• Degree in Science/Engineering or related discipline.
• Minimum of 3 years validation experience in pharma or biotech.