Our client, a global biologics corporation specialises in providing end to end solutions for the development and manufacturing of biologics in North Leinster. They are known for their state-of-the-art facilities and expertise in the biopharma industry. They are currently seeking to hire a Senior QA Validation Engineer for a 12 month contract.

The Position

• Quality review and approval of qualification/validation documentation and associated data for conformance to regulations, standard operating procedures (SOPs), specifications and other applicable acceptance criteria.
• Ensure all equipment and processes are safe, effective, and qualified in compliance with industry standards and regulatory expectations.
• Participate in event deviation investigation and change evaluation during qualification, to ensure the systems and equipment meet quality and compliance requirements prior to release.
• Responsible for ensuring that all manufacturing processes, QC and enterprise systems perform and operate as per their design.
• Work with all personnel, contractors, and visitors to ensure that all safety policies, procedures and regulations are fully adhered to across the site on an ongoing basis.

The Person

• Good understanding of the principles of qualification and validation of equipment and utilities.
• Strong experience in a quality engineering/quality assurance role for biologics, medical device or pharmaceutical manufacturing.
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• Ability to operate across functional boundaries, both internal and external.

The Benefits

• 12 month contract.
• Competitive hourly rate.
• Co Louth location.

To discover more about this opportunity please apply online or contact Olivia Rogers at HRM on +353 1 632 1802 for a confidential discussion.