Senior Scientific Technical Specialist

at  PE Global

OVERVIEW:

• A fantastic opportunity has arisen for a Senior Technical Transfer Specialist to join our growing Engineering team. You will lead, collaborate and facilitate running of activities (e.g. scale-up, PPQ batch manufacture, license submissions, technical troubleshooting and audit readiness) for Technology Transfer of processes to ensure the effective and efficient on-time delivery of these activities to the Vaccines Integrate Process Team (IPT).

EDUCATION AND EXPERIENCE:

• Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).
• Project management qualification such as, Project Management Professional is desirable.
• Preference for Lean Six Sigma qualification or experience of application of Lean principles
• > 6 years’ experience in biopharmaceutical/vaccines environment.
• Experience of leading projects; leading technical projects is distinct advantage.
• Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
• Demonstrated knowledge in one or more pharmaceutical or Biopharmaceutical manufacturing operation (e.g. manufacturing operations, technology, validation, engineering, quality.).
• Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
• Experience in an FDA / HPRA Regulated production environment.

THE ROLE:

PE Global is currently recruiting for a Senior Scientific Technical Specialist on behalf of a leading pharmaceutical company based in Cork. This is an initial 11-month contract role.

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/lead 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.
• 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.
• 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.