Senior Scientific Technical Specialist
5 hours ago
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. 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). 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 teams performance within the Vaccine Technology Transfer group in the Technical Operations Dept. Responsible for the technical transfer and scaleup 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. 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. Interested candidates should submit an updated CV. Please click the link below to apply, call Kellie on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: tech transfer project management quality
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