Technical operations Specialist

This is initially a 11 month contract position, offering a lucrative hourly rate.

An amazing opportunity has arisen for a Technical Specialist in Operations – Vaccines IPT. The Technical Specialist will provide process technical support to the Vaccines IPT team and other site departments which require Vaccine Process knowledge support, the role will be reporting to the Vaccines IPT Associate Director.

Duties of the role/Responsibilities:

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Support department and site level activities that require process and operational knowledge.
• Support process operations including trouble shooting technical and process related issues and leading investigations utilising MPS principles i.e. DMAIC/A3/OPPS etc.
• Managing EHS and Quality investigations, coaching, completing and overseeing batch record reviews.
• Lead cross-functional Technical Projects to further develop the Vaccine Process.
• Support and management of Process Robustness changes and product introduction.
• Lead cross-functional Projects problem-solving teams for troubleshooting and investigations within Vaccines IPT and across the site as required.
• Vaxneuvance POC for site compliance initiatives.
• Be responsible for providing a high level of process knowledge to supporting functions and projects.
• Support and lead material management and troubleshooting with a cost focus.
• Apply Lean Six Sigma and Lean methodologies.
• Represent the department on cross-functional project teams.
• Adherence to highest standards for Compliance (Safety, Quality and Cost)
• Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

Education/Experience

In order to excel in this role, you will more than likely have: 

• Degree or Masters in a Science or Engineering discipline (Preferably Biotechnology).  
• > 4 years’ experience in biopharmaceutical/vaccines environment. 
• Knowledge in material management and associated systems. Direct experience with Single Use Technology i.e. operational use, problem solving, vendor engagement.
• Direct experience in manufacturing with a problem-solving mindset. (Preferably Vaccine Drug Substance)

• Strong technical and process knowledge with background and experience in drug substance processing unit operations including UF/DF, Lyophilisation, Bottle filling, PAT, Single use technology deployment.
• Strong collaboration and project management skills; able to establish good working relationships with employees at all levels, resolve conflict and provide feedback, and to devise and implement creative solutions to problems
• Knowledge of FDA / HPRA Regulations and applicable standards for Quality and Regulatory requirements within the biopharmaceutical/vaccine area.
• Demonstrated successes in a cross functional team environment, such as project teams. 
• Demonstrated ability to solve complex technical problems; taking a new perspective using existing solutions.
• Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
• Works independently, receiving minimal guidance.
• Demonstrated ability to forecast, plan and monitor cost with regard to material consumption,

Interested candidates should submit an updated CV.

Please click the link below to apply, call Chloe on 086 0200448 or alternatively send an up to date CV to chloe.slingsby@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***