18369 – Associate Technical Specialist – Cork Contractor

Purpose

This role will report to the Associate Director of Lab OPs.

The Associate Technical Specialist will demonstrate a high level of innovation, enthusiasm and for the delivery of improvement projects with the Lab Ops area as well as day-to-day base business support.

This requires a flexible, collaborative, and coaching style within the IPT process, engaging and communicating with all IPT members

Responsibilities

• Provide Technical Support for the commissioning and qualification of laboratory equipment including equipment IOQ and PQ
• Work with site support groups to deliver qualified raw materials and consumables for the manufacturing process.
• Author, review and approve manufacturing documentation associated with transferred processes.
• Troubleshoot technical issues and lead investigations through scientific problem-solving approaches.
• Partner with quality groups to support change management to implement process improvments
• Generate study plans, protocols and summary reports
• Establish and lead implementation the continued process verification program to effectively manage product life cycles.
• Adherence to highest standards for Compliance (Quality and Safety)
• Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, regulatory inspections and incident investigations.
• Actively participate in a culture of Continuous Improvement and process optimisation by deploying Six Sigma tools.
• Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

Requirements

• BSc Degree in Biochemistry, Microbiology, Chemistry, Engineering or a related field
• 3+ years’ experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience
• Experience in at least two of the following areas protein chemistry, process engineering, cell culture, purification technologies, process operations, statistics, technology transfer, microbiological control of bio-manufacturing processes, cleaning validation, process validation, regulatory inspections.
• Evidence of Continuous Professional Development and cross skilling