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.
- 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