Job description

GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services (CQV) to the life sciences and technology sectors. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client’s needs.

We are hiring for Process Specialist for the Sligo region.

Job Requirements

• Provide technical support for the Manufacturing Process and Equipment.
• Sourcing and procuring process equipment including technical oversight of procurement process.
• Identification and project management of continuous improvement projects. Work closely with all leaders to monitor and where necessary implement improvement initiatives in line with continuous improvement philosophy.
• On site ownership of manufacturing equipment, process knowledge and technology.
• Establishing/confirming specifications for process parameters, process controls and equipment effectiveness.
• Develop and modify procedures as needed to support the manufacturing operation.
• Participate in process, equipment, and facilities validations efforts and projects implementations.
• Support the introduction of new products and process to site, working alongside all functions.
• Oversight of planning, executing, and reporting for all process related aspects of technology transfer projects.
• Establish and maintain statistical process control systems in collaboration with Manufacturing and Quality functions.
• Adhering to all relevant policies relating to Quality & Safety.

Education & Key Requirements

• A relevant third level qualification in an engineering, science or technical discipline (Preferred masters or PhD in engineering, chemical or process engineering)
• 3-5years plus professional experience preferably in process engineering, with relevant experience of batch processing, technical transfers, scale-up, commissioning and validation in a cGMP pharmaceutical or Biologics industry
• Good knowledge of quality systems both FDA and EU regulations as they relate to manufacturing, facilities and process engineering.
• High level of attention to detail & strong interpersonal skills
• Troubleshooting skills and excellent attention to detail

#INDHP

Job Type: Full-time

Schedule:

• Day shift

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