19680 - Technical Specialist - Cork

This is an 11 month contract with a view to extension

Purpose

An amazing opportunity has arisen for a Technical Specialist – PCV Process Support. This position will provide technical support to the Tech Ops V114 technical team to support equipment commissioning, qualification and validation, project management for critical projects in support of vaccines manufacture meeting our Manufacturing Division Priorities of: Compliance, Supply, HPO, Strategy and Profit Plan

Responsibilities

• Ensure the highest Quality, Compliance and Safety standards primarily with equipment qualification, commissioning and validation, project management but relating to all activities.
• Work within a team to enable the team’s performance within the Technology Transfer group and Tech Ops.
• Responsible for the qualification of new equipment to support vaccine manufacturing, providing technical support to the team and leading projects/project management.
• Development and execution of protocols to support equipment qualification.
• Technical Review, ownership of and impact assessment of Global Change management records as required.
• Recommend technical approaches in line with global and local standards.
• Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.
• Contribute for driving a culture of Continuous Improvement by deploying MPS within Tech Ops on projects such as: problem solving, reducing cycle time, Lean principles within the new processes.
• Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
• Participate and comply with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
• Lead Knowledge Management efforts within the team.

Requirements

• 5-10 years’ process engineering experience in biopharmaceutical/vaccines environment would be an advantage.
• Prior experience with equipment commissioning, qualification, and validation.
• Prior experience with Lyophilisers would be an advantage.
• Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations. Experience of involvement in a technical project an advantage
• Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
• Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).
• Preference for Lean Six Sigma qualification or experience of application of Lean principles
• Project management qualification such as, Project Management Professional is desirable
• Prior equipment qualification experience required.
• Managing complex project and aligning key stakeholders.
• Evidence of Continuous Professional Development