Orion Group Life Sciences are currently recruiting a Technical Operations Specialist on behalf of our Multinational Biopharmaceutical Client based in Cork on an initial 11-Month contract with potential to extend.
 
Days, Onsite Role
 
 
Responsibilities:
 

• 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.

 
 
What skills you will need: 
 

• 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 regarding material consumption,

 

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.