Technical Specialist in Operations Vaccines IPT

About PSC Biotech

Who are we

PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

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.

Requirements

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 crossfunctional Technical Projects to further develop the Vaccine Process.
  
• Support and management of Process Robustness changes and product introduction.
  
• Lead crossfunctional Projects problemsolving teams for troubleshooting and investigations within Vaccines IPT and across the site as required.
  
• 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 crossfunctional 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:

• Hon. 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 problemsolving 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