17402-Technical Specialist-Cork Contractor

This is an 11-month contract.

Purpose:

This position will provide technical support to the Vaccines IPT to support the technology transfer and filing requirements for Vaccines IPT manufacture meeting the Company Manufacturing Division  Priorities of Compliance, Supply, HPO, Strategy, and Profit Plan.

Responsibilities:

• Ensure the highest Quality, Compliance, and Safety standards primarily with Technology Transfer but relating to all activities.
• Work within a team to enable the team’s performance within the Vaccine Technology Transfer group in the Technical Operations Dept.
• Responsible for the technical transfer and scale–up of a new process into Vaccines IPT.
• Input into Technical planning and decisions for the Vaccines IPT, to ensure supply of high-quality products through tactical planning and execution of production schedules.
• Technical Review, ownership of, and approval of Global Change management records as required.
• Recommend technical approaches in line with global and local standards.
• Benchmark and remain current with the 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 to driving a culture of Continuous Improvement by deploying Merck Six Sigma tools and MPS within the IPT on projects such as problem-solving, reducing cycle time, and Lean principles within the new processes.
• Stakeholder management of multiple decision makers, corporate colleagues, and cross-functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
• Participate and comply with the  Quality Management System (QMS) requirements, including ownership, as relevant.
• Responsible for supporting a culture of Continuous Improvement by championing Six Sigma tools within Technology Transfer for Vaccines IPT.

Minimum Qualifications & Requirements:

• Hon. Degree or master’s 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.
• Evidence of Continuous Professional Development.
• 3 years plus experience in the biopharmaceutical/vaccines environment.
• Trackwise/ SAP experience would be an advantage.
• Demonstrated knowledge in pharmaceutical/biopharmaceutical technical/manufacturing operations. Experience of involvement in a technical project and advantage.
• Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
• Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical manufacturing operation (e.g. manufacturing, technology, validation, engineering, quality)
• Demonstrated ability in holding project team members responsible for results and being decisive about non-performers.
• Demonstrated ability to realize improvement initiatives.
• Demonstrated successes in a team environment, such as project teams, Six Sigma teams, PITs, etc.
• Demonstrated high level of problem-solving and facilitation skills.
• Advanced PC skills such as Excel, Word, and PowerPoint.
• Stakeholder management of multi-decision makers, colleagues, peers, and cross-functional teams.
• Experience in an FDA / HPRA Regulated production environment.