Manufacturing Process Specialist

Manufacturing Process Specialist

Team Horizon is seeking a Manufacturing Process Specialist for a client in Sligo to support Pharmaceutical Operations and provide technical leadership and direction for the manufacturing department across several areas including formulation, aseptic filling process, isolator technology and representation at various regulatory audits.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  
  
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
  
  
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
  
  What you will be doing:
  
  
• On site ownership of manufacturing equipment, process knowledge and technology
  
  
• Sourcing and procuring process equipment including technical oversight of procurement process.
  
  
• Provide technical support for the Manufacturing Process and Equipment Collaborate with technical groups and experts across the network, ensuring consistency of technical approach and technical standards to strive for best-in-class performance.
  
  
• Design and implement technical studies and programs as appropriate to support investigations and product improvements.
  
  
• Develop knowledge of new pharmaceutical manufacturing processes as required in line with company business objectives.
  
  
• Identify and project manage continuous improvement projects. Collaborate closely with all leaders to monitor and where necessary implement improvement initiatives in line with continuous improvement philosophy.
  
  
• Continuously drive to improve processes for improved performance and cost reduction wherever possible.
  
  
• Establish/confirm specifications for process parameters, process controls and equipment effectiveness.
  
  
• Establish and maintain statistical process control systems in collaboration with Manufacturing and Quality functions.
  
  
• Monitor and analyse process data during the manufacturing of drug product.
  
  
• Oversight of planning, executing, and reporting for all process related aspects of technology transfer projects.
  
  
• Support the introduction of new products and process to site, working alongside all functions.
  
  
• Lead teams on identifying root cause and corrective actions for process deviations using best practice problem solving and continuous improvement methodologies in collaboration with other functions.
  
  
• Assuming accountability for risk assessments, including hazards, for the health and safety of company employees and visitors.
  
  
• Develop and modify procedures as needed to support the manufacturing operation.
  
  
• Participate in process, equipment, and facilities validations efforts and projects implementations.
  
  
• Consult with operations, quality, and S&T to ensure equipment and process performance is maximized.
  
  
• Adhere to all relevant policies relating to Quality & Safety.
  
  
• Ensure successful external inspections, and Division and Corporate audits.
  
  
• Supervision of external contractors.
  
  What you need to apply:
  
  
• A relevant third level qualification in science, engineering, or technical discipline. Master’s or PhD in engineering, chemical or process engineering would be an advantage.
  
  
• Minimum of 3 years’ experience in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale-up, commissioning and validation in a cGMP pharmaceutical or Biologics industry
  
  
• Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements
  
  
• Previous experience in lyophilization and sterilization operations is preferable