The Senior Engineer II will lead projects that help transform Shire Lexington Manufacturing Site into a new product launch Center of Excellence (COE). The key deliverables for this function include:
• Translate Launch CoE vision and strategy to deployment with focus on project execution
• Lead improvement projects to drive site capacity utilization and/or throughput.
• Provide Technical Services to ensure right first time for process installation and process changes
The Senior Engineer II is responsible for driving the organization towards a culture of collaboration, accountability, accuracy, and efficiency. The primary objectives are to ensure effective execution of process installation and site improvement projects, timely execution of deliverables related to expedite new product launch to be first-in-market. Additionally, the Senior Engineer II will be responsible for supporting Tech Transfer representing the receiving unit. Lead projects of various complexities to support departmental initiatives and participate in cross-functional teams to support cross-network activities.
65% Support New Product Launch COE
Lead in activities and projects to establish Shire Lexington Site as new product Launch Center of Excellence:
• Work to establish, revise and obsolete procedures to improve business process.
• Work with tech transfer teams, PDTS teams, Manufacturing, and other stakeholders to clearly define scope of work, objectives, and deliverables.
• Routine reporting of progress and status of projects to management.
• Ensure documentation support is provided for compliance purpose.
• Effectively communicate ideas, project goals, and results.
• Foster teamwork and drive project/process improvements.
• Expected to lead cross functional projects and teams
20% Support Network Strategy Implementation
• Actively develop, support and manage projects / activities as they relate to Shire Network Strategy Implementation
15% Support Regular Team Activities
• Lead or participate in Implementation of CAPAs and change controls in response to investigation findings and process improvement initiatives.
• Identify and schedule project events around manufacturing operations
• Communicate events effectively to the Scheduler and impacted groups
Education and Experience Requirements
• BS/MS Degree in Science, Engineering or related pharmaceutical field. (or an equivalent combination of education and relevant experience)
• Eight to ten years in experience in Pharmaceutical, biotech product development or commercial manufacturing operation support.
• Proven record of technical leadership, including ability to influence, motivate, and drive technical rigor.
• Project management experience and demonstrated ability to manage large cross functional teams, familiarity with OE tools is a plus.
Location/Region: Lexington, MA