GerTEK Project Management & Technical Services are an outsourced technical services provider delivering worldwide contract and permanent staffing solutions. We are accepting applications for our Manufacturing Process Engineer based in Sligo.

Job Description

• Provide technical assistance to the manufacturing areas related to the manufacturing process and equipment
• 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.
• Developing knowledge of new pharmaceutical manufacturing processes as required in line with company business objectives.

• Continuously drive to improve processes for improved performance and cost reduction wherever possible.
• Establish and maintain statistical process control systems in collaboration with Manufacturing and Quality functions.
• Monitoring and analysis of 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 utilising best practice problem solving and continuous improvement methodologies in collaboration with other functions.
• Participate in process, equipment, and facilities validations efforts and projects implementations.
• Ensure successful external inspections, and Division and Corporate audits.

Education & Key Requirements

• Preferred masters or PhD in engineering, chemical or process engineering or degree educated in an engineering, science, or technical discipline
• 3 years plus professional experience preferably in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale-up, commissioning and validation in a cGMP pharmaceutical or Biologics industry
• Experience in new product introductions is desirable
• Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements are required
• High level of attention to detail & strong interpersonal skills