Bds Manufacturing Technologist

Kenny Whelan And Associates

Cork

BDS Manufacturing Technologist x 2. Duties: Manufacturing Technologists are responsible for Manufacturing Support to the BDS operations. They help to build and sustain employee engagement by creating a culture of open, efficient execution and an environment in which individuals and teams can excel and continuously improve. The level 3 manufacturing technologist is a senior role, which requires significant subject matter expertise and provides technical leadership, leading complex projects relating to improvements and investigations within the BDS operations function. Leader and provider of expert technical and documentation support to investigations, CAPA’s, change controls, training and improvement projects ensure the manufacture of bulk drug substance is performed in a safe, compliant, cost effective manner meeting the regulatory requirements defined in relevant health authority submissions, cGMPs and local Health and Safety requirements. During the start-up project and routine new product introductions, the Manufacturing Support team provide end user operations requirements input into design, commissioning and validation of equipment, automation and processes as part of multi-function project teams. The Manufacturing Support team takes a lead role developing Operations procedures, batch records (electronic or paper as required), other documentation and provide technical training to the Operations teams. Manufacturing Technologists take an active role in setting up work practices and procedures that minimize human error, and work with operations continuous improvement teams to remove sources of error. Manufacturing Technologists successfully lead teams to deliver all project requirements associated with cost, time and functionality, ensuring that all KPI targets are achieved. The Manufacturing Support team Develop and maintain strong and effective relationships with partners including Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources and Finance. They lead and contribute to best practice sharing with manufacturing and technical colleagues at other company facilities and across the industry. Skills: A minimum of 8 years’ experience in Manufacturing Operations, Technical Support or Equipment Engineering in a biopharmaceutical company or closely aligned industry. Extensive knowledge of biological manufacturing processes. Significant experience with leading projects in areas such as media prep, buffer prep, sterile filtration, upstream and downstream unit operations. Experience of formulation, aseptic and sterile manufacturing, including, autoclaves, sterile filtration, Vial and Syringe packaging would be an added advantage. Experience of capacity expansion and new product introduction project work is essential and experience of a green field start-up is desirable. Experience in investigating complex manufacturing investigations, CAPA’s and Change Controls. Good knowledge of GMP/HPRA/FDA regulatory requirements and current Health and Safety Regulations legislation. Well-developed analytical, numerical and computer skills and the ability to combine hands-on activities with theoretical knowledge and expertise. Good Presenting and Training Skills. Good Technical writing skills. Excellent communications and decision-making skills. Min Green Belt in Lean six sigma. Proven ability to work well as part of a team & on own with minimum supervision. Proven leadership skills. Other duties as required. Education: Undergraduate degree in science or engineering or equivalent is required. This job originally appeared on RecruitIreland.com.

1801 days ago