3/4/2025 A Manufacturing Process Specialist

4 weeks ago

Sligo, Sligo, Ireland TEAM HORIZON Full time

Manufacturing Process Specialist Team Horizon is seeking a Manufacturing Process Specialist for our pharmaceutical client in Sligo. As a Manufacturing Process Specialist, you will play a key role in providing technical leadership and support for manufacturing operations. The successful candidate will be at the forefront of room and equipment qualification, developing SOPs for new manufacturing processes, collaborating with vendors for equipment procurement, and establishing critical processes. 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 peoples 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: Serve as a Subject Matter Expert (SME) in formulation, aseptic filling processes, and isolator technology. Represent the team at regulatory audits. Own manufacturing equipment, process knowledge, and technology. Source and procure process equipment with technical oversight. Provide technical support for manufacturing processes and equipment. Collaborate with technical experts across the network to ensure consistency and best practices. Design and implement technical studies and programs to support investigations and product improvements. Develop knowledge of new pharmaceutical manufacturing processes. Identify and manage continuous improvement projects. Drive process improvements for enhanced performance and cost reduction. Establish specifications for process parameters, process controls, and equipment effectiveness. Implement statistical process control systems. Monitor and analyze process data during drug product manufacturing. Oversee planning, execution, and reporting for technology transfer projects. Support the introduction of new products and processes. Lead root cause analysis and corrective actions for process deviations. Develop and modify procedures to support manufacturing operations. Participate in process, equipment, and facilities validation efforts. Liaise with operations, quality, and S&T to optimize equipment and process performance. Adhere to relevant quality and safety policies. Ensure successful external inspections and audits. Supervise external contractors. What you need to apply: Minimum level 8 qualification in an engineering, science, or technical discipline At least three (3) years in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale-up, commissioning and validation in a cGMP pharmaceutical or Biologics industry Specific experience in process validation to US/EU markets Strong record of achievement Demonstrated experience of technical writing of complex issues. Must have experience in taking a lead role in investigations. High level of technology experience Good knowledge of quality systems both FDA and EU regulations as they relate to manufacturing, facilities, and process engineering. 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. Experience working with lean methodologies is desirable. Previous experience in lyophilization and sterilization operations preferable Skills: process engineering tech transfer batch processing cGMP Technical Writing NPI Lean methodologies Benefits: Paid Holidays Pension Fund Medical Aid / Health Care

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