Position Summary

The Manufacturing Engineering Manager (MEM) will be responsible for the successful execution of projects identified as part of the Athlone site project priority list. These projects will be in several categories, including the following: new process / equipment remediation, process innovation and automation, product transfers / feature enhancement, new material & equipment qualification, process optimisation, continuous improvement (CAPEX & OPEX) / cost reduction in facilities and maintenance. The MEM main area of responsibility will be the technical engineering ownership of an aseptic sterile fill finish facility and will provide technical leadership on any process or equipment issues in line with business strategies and objectives. The role will require the MEM to understand the user requirements and work closely with vendors to ensure these requirements are incorporated into the equipment and facility.

Principal Responsibilities

• Acts as an advocate for continuous improvement activities in the sterile fill finish facility using statistical techniques, lean manufacturing tools, six sigma, design experimentation for process and equipment, FMEA, to achieve targets and cost savings.
• Take the lead in troubleshooting on process equipment where required. Manage, mentor and coach team of Process Engineers and Maintenance Technicians.
• Work collaboratively to lead a safe and compliant culture in Alexion.
• Develop and Maintain Drug product Engineering Operations department operational budget.
• Ensure the equipment design meets regulatory and user requirement specifications.
• Act as the client point of contact for all vendor interactions to ensure successful design, testing and equipment delivery to site.
• Successfully lead teams to deliver all project requirements associated with cost, time and functionality, ensuring that all KPI targets are achieved.
• Lead projects through use and modification of User Requirement Specifications (URS) matching customer needs, project charters, work breakdown structures, capital expenditure requests (CERs), project plans, site and factory acceptance test protocols.
• Track and report out on projects using standard Alexion templates, ensuring all necessary information is available to key Stakeholders, e.g. Operations, Quality, Validation, Finance and Engineering.
• Work closely with other site functions to ensure a smooth transition between project and operational phases.
• Responsible for managing team of equipment/process engineers and maintenance technicians.
• Support and develop all individuals within the Engineering Operations DP team.
• Key contributor/leader in DP NPIs. Responsible for recipe development and testing.
• Act as main point of contact for product complains, investigations for technical engineering.
• Manage increase in commercial product range and format expansion in process equipment, recipe and format management.
• Delivery of lean process to DP engineering, 5S, Standard Work, TMP and Own and Drive the Lean Culture within the DP Engineering Operations team.
• Foster and develop a culture of Right First Time.
• Drive and deliver on equipment upgrades and retrofits.
• Be a key contributor/leader for yield improvement initiatives, scrap reduction and equipment utilisation.
• Represent the Engineering Operations Team, and functional Unit where necessary, in the absence of the AD Engineering Operations, including SLT & Tier meetings.

Qualifications

• Minimum of 8 years of experience working in a technical engineering role in the Pharmaceutical / Biotechnology industry.
• Significant experience with leading projects in areas such as media prep, buffer prep, formulation, aseptic and sterile manufacturing, including high speed aseptic filling lines, autoclaves, sterile filtration, depyrogenation, Vial filling and automated visual inspection.
• Experience or good working understanding of the installations/validation of pure steam and water systems, compressed air, utilities, WFI, clean steam, chilled water systems, building management system, AHU's, & biopharma manufacturing vessel systems.
• Demonstrated ability to work effectively with vendors and resolve issues in a timely and structured manner.
• Well-developed analytical, numerical and computer skills and the ability to combine hands-on activities with theoretical knowledge and expertise.
• Good knowledge of GMP/HPRA/FDA regulatory requirements and current Health and Safety Regulations legislation.
• Good technical capabilities, communication skills, teamwork abilities and initiative.
• Proven ability to work well as part of a team & on own with minimum supervision.

Education

• HETAC Level 8 qualification in pharmaceutical, chemical or mechanical engineering or related engineering field.

Date Posted

15-Jul-2024

Closing Date

05-Aug-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.