Technical Transfer Specialist

The Role:

This position will provide technical support to the Vaccines IPT to support the technology transfer and scale-up of new processes for Vaccines IPT manufacture meeting the 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 product through tactical planning and execution of production schedules.
• Technical Review, ownership of and approval of Change Control, Quality Notification,
  deviation and investigation 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 the
  IPT 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 the MMD Quality Management System (QMS) requirements, including ownership, as relevant.

Requirements:

• 4 years’ experience in biopharmaceutical/vaccines environment
• 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.

Qualifications:

• 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
• Evidence of Continuous Professional Development
Skill Set: • 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.
• Demonstrated high level of problem solving and facilitation skills.
• Advanced PC skills such as Excel, Word, PowerPoint.
• Stakeholder management of multi decision makers, colleagues, peers and cross
functional teams.
• Experience in a FDA / HPRA Regulated production environment.

Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to niamh.mcdonald@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***