- The MMDIT Lead Engineer for labs will be responsible for delivery of Automation and IT scope on one or more lab projects in the portfolio of capital projects managed.
- This candidate will be required to work closely with the MMDIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for delivery of systems.
- Involving projects for the introduction of new products, equipment and processes to meet all safety, quality, regulatory and operational requirements.
- Process mapping, gap analysis/identification for new and existing pharmaceutical manufacturing processes.
- Process development (as part of technical transfer), troubleshooting and optimisation.
- Project engineering including planning, scheduling, task management and delegation, milestone planning, communication and reporting.
- Delivering projects on time and on budget.
- Executing process and equipment trials and validation.
- Leading cross functional teams as part of project planning and deployment including collaboration with supporting departments such as Production/Operations, Quality, Safety, Regulatory Affairs, Facilities and Engineering, Supply Chain and Finance, Project scoping and gap analysis.
- Partner with local project teams to deliver Automation and IT aspects of Laboratory capital projects.
- Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with MSD standards.
- Coach, mentor and provide technical training to colleagues.
- Understand and educate local project teams on automation standards as they relate to technology selection, system configuration, SDLC, validation, hardware, software environments and business processes.
- Work closely with the QAIT function to ensure compliance with MSD Quality standards.
- Provide input to the development of project schedules and document trackers.
- Participate in, and support, relevant project meetings.
- Support the development and execution of project staffing plans if required.
- Drive efficiencies in execution of projects to reduce costs and cycle times based on standards.
- Engages with stakeholders at all levels of projects.
- Ensures that SDLC is appropriately applied.
Education & Qualifications Required
- BS in Engineering, Computer Science, or other technical degree.
- 7 or more years of experience in project/automation/IT support in a similar role with experience in laboratory analytical instrument qualification.
- Excellent facilitation, problem solving, and decision-making skills.
- Demonstrated ability to analyse and define business problems, develop business cases, and identify appropriate process and technological solutions is essential.
- Proven facilitation, meeting/workshop management, project management and change management skills are essential.
- Excellent written and oral communication skills, as well as strong presentation skills.
- Experience with Laboratory systems such as LIMS, Empower and Nugenesis
- Experience in automation equipment used in Laboratory an advantage
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100