Cork, County Cork, Ireland
I am an experience Manufacturing Professional serving as a Manufacturing Coordinator / Engineer at a leading multinational biopharmaceutical company. I bring expertise in manufacturing processes to ensure efficient production and quality control, specializing in the production of bulk drug products. I have 15 years of experience as a Production Manager in a top-tier manufacturing facility producing precision-engineered components, with extensive expertise in Lean Management, Campaign Management, and leading cross-functional teams to address operational and quality nonconformities. I excel in both oral and written communication, am highly organized, and focus on setting clear direction and meticulous attention to detail. My goal is to drive business activities forward while ensuring compliance with cGMP procedures and safety standards. I have strong leadership skills with emphasis on empathy, accountability, and productivity. Continually striving to learn, share knowledge, and develop people and teams.
• Manufacturing Engineer role within the bio pharmaceutical manufacturing facility, encompassing additional responsibilities stemming from the solid and capsule dosage pharmaceutical site. • Spearheading project management efforts for validation and qualification processes, overseeing IOQs and PPQ batches to facilitate seamless scaling up into GMP Commercial activities. • Providing technical support to Operational functions through the continuous assessment and implementation of technical writing of Batch Records, SOP’s, Change Plans and Training plans • Lead and deliver on key activities and projects as identified by the Operations Manager & Production Manager on an on-going basis. • Improve safety of the manufacturing area in conjunction with other departmental representatives. Using identified trends as part of the safety management system to target improvement areas • Communication across departments as a product Campaign Manager, working together to achieve improved performance and achieve high product quality yield. • Improve compliance of the manufacturing area in conjunction with other departmental representatives. Use issues as identified as part of the Quality Management System such as NCR’s, Operational Notes, Virtus Quality System and Compliance Walkdowns to target improvement areas. • Presenting to site SLT & ELT on project updates and outcomes, weekly campaign updates on product campaign performance on successes, challenges and look aheads, with a clear and courageous mindset. • Analyzing & collecting data on critical parameters to anticipate potential process constraints. Communication of these reports, updating with the team & management • Target areas of downtime through various forums to target improvement areas in production and across the site. • Collaborate with Cross functional teams on Change Review Boards as part of expansion works to be carried out on site and to ensure all risk management assessments have been adhered to.
• Providing technical support to Operational functions through the continuous assessment and implementation of technical writing of Batch Records, SOP’s, Change Plans and Training plans • Lead and deliver on key activities and projects as identified by the Operations Manager & Production Manager on an on-going basis. • Improve safety of the manufacturing area in conjunction with other departmental representatives. Using identified trends as part of the safety management system to target improvement areas • Communication across departments as a product Campaign Manager, working together to achieve improved performance and achieve high product quality yield. • Improve compliance of the manufacturing area in conjunction with other departmental representatives. Use issues as identified as part of the Quality Management System such as NCR’s, Operational Notes, Virtus Quality System and Compliance Walkdowns to target improvement areas. • Presenting to site SLT & ELT on project updates and outcomes, weekly campaign updates on product campaign performance on successes, challenges and look aheads, with a clear and courageous mindset. • Analyzing & collecting data on critical parameters to anticipate potential process constraints. Communication of these reports, updating with the team & management • Target areas of downtime through various forums to target improvement areas in production and across the site. • Collaborate with Cross functional teams on Change Review Boards as part of expansion works to be carried out on site and to ensure all risk management assessments have been adhered to.
• Coordinated production orders to achieve weekly and monthly build plans, meeting materials planning schedules and inventory goals. • Maintained daily communication with the team, ensuring adherence to daily build plans and production schedules. Facilitated effective shift handovers by communicating process status and any issues encountered. • Managed a team of 20 production personnel: • Conducted performance reviews, appraisals, and promotions. • Interviewed, hired, and trained new employees. • Fostered positive working relationships between management and production staff. • Documented all process work instructions and procedures as part of a collaborative team. • Collaborated with maintenance and technical support to address potential process disruptions and equipment failures. • Maintained high safety standards and adhered to ISO 9001 and ISO 14001 principles. • Ensured effective communication during shift handovers, providing process updates and details of any issues/problems with builds. • Participated in the introduction of Lean Management principles and served as a project champion for these initiatives within the plant. • Acted as the lead 5S coordinator, lead KPI scorer, and oversaw the implementation of Action Lists and SMED Reports. • International and National travel to key vendors and customers.
• • Trained in all aspects of production throughout the factory floor to learn all aspects of processes and Health & Safety, including lathe and milling machines. • Assisting the Production Manager with production process, planning, supervision, and quality control as part of the team • Scheduled routine inspection and maintenance of production equipment to prevent equipment break-downs and malfunctioning • Develop and update standard operating procedures and best practices for production operations • Operating on a 2 cycle shift basis • Review all production documentation and confirm they are accurate • Member of a team monitoring safety measures and procedures that are followed to eliminate incidents and hazards. • Assisting with the team monitoring that production processes are carried out in accordance with company policies and procedures.
• Finding resolutions for our client’s challenges and offering them the best financial advice • Provide on-going service and advice to clients and building strong relationships • Worked to always achieve and surpass all agreed targets and standards using SAP software. • Contributed to the development of marketing materials and information email blasts