Role Overview:
You will be part of the larger Technical Engineering Department and responsible for leading an integrated project team in delivering the project business case.
Key Responsibilities:
- Oversee project lifecycle: scope, design, installation, qualification, and handover.
- Maintain alignment with project business cases through close collaboration with project sponsors.
- Develop and manage project scope, budgets, and schedules in coordination with project managers and cross-functional teams.
- Present project updates to the Capital Approval Committee and integrate Computer Systems Validation as required.
- Apply risk-based approaches to troubleshooting and investigations, leveraging scientific and process knowledge.
- Act as a subject matter expert in equipment design, qualification, and lean methodologies to drive operational improvement.
- Foster continuous improvement through Kaizen events, root cause analysis, and change management.
- Liaise with global engineering, facilities, and external vendors to ensure on-time project delivery.
- Champion a safe, compliant, and collaborative work culture.
Qualifications & Skills:
- Significant experience leading large capital projects (>€5MM) in sterile manufacturing environments.
- Strong knowledge of regulatory requirements and sterile filling processes, including equipment validation.
- Proficiency in QbD, CPV, automation, MES, and Microsoft Office.
- Lean Six Sigma certification and experience in audits are advantageous.
- Exceptional communication, people management, and vendor management skills.
- Proven ability to deliver projects on time and within budget while driving continuous improvement initiatives.
Desired Attributes:
- Strong safety ethos with customer and patient focus.
- Ability to lead through change, plan effectively, and foster innovation.
For a confidential discussion and more information on the role, please contact Kevin Griffin
Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108