Engineering Services Lead

Job Title

Engineering Services Lead

Requisition

JR000014858 Engineering Services Lead (Open)

Location

Dublin, IRL

Additional Locations

Job Description Summary

Reporting to the site engineering manager, the Engineering Services Lead is the responsible for the following key areas
- Responsible for the management of the process equipment and process utilties lifecycle including annual requalification, periodic reviews, annual reports and change management.
- Responsible for automation providing operational support to CPMF.
- Responsible for managing the site capital program.
- Sponsor engineering safety programs.
- Provide SME support and participate in regulatory inspections.
The Engineering Services Manager must ensure that all engineering equipment and computerised activities are aligned with current Services standards and are executed to schedule and in accordance with company and statutory requirements. The Engineering Services Manager is responsible for ensuring all systems are validated and their validated status is maintained throughout the lifecycle of the system.
The Engineering Services Lead leads a team of direct reports, contractors and third-party service providers, responsible for various engineering disciplines that deliver critical services to enable manufacturing and support operations in Laboratories, Warehouse, office spaces and Process Development.
The team is responsible for Capital Projects, Commissioning, Qualification and Validation (CQV) execution and Automation systems. The team is expected to perform all duties in compliance with Good Manufacturing Practices (cGMPs) and EHS regulations and best practices.

Job Description

• Manage an engineering organization capable of delivering key projects and supporting sustaining operations.
• Build and sustain employee engagement by creating a culture of inclusion and transparency in which individuals and teams can continuously improve.
• Foster strong working relationships with Site Engineering, Manufacturing Operations, Technical Operations, Quality and EHS to ensure compliant reliable manufacturing activities.
• Ensure Engineering teams initiate and complete investigation, deviations, CAPAs, and Change Controls as assigned and using structured investigation tools.
• Maximize the success rate for production operations by instituting programs to minimize technical failure and procedural errors.
• Support Inspection Readiness activities, while leading the Engineering services readiness plan.
• Provide expertise and leadership during regulatory inspections.
• Support strategic plans for process and plant improvements.
• Drive implementation of engineering capital projects.
• Develop a site capital master plan and gain corporate approval for capital projects.
• Sponsor engineering safety programs within the maintenance and utilities structure including
• Implement project management policies and procedures for the site that align with corporate engineering, regulatory expectations, and best-practices.
• Mange the prioritization of projects / tasks in line with the site requirements & strategic Quality, Engineering and Operations objectives.
• Maintain capital project budgets and cash flow forecasts. Track and report actual expenditures against forecasts.
• Develop, implement, and own a comprehensive engineering strategy for the site that provides for a direction for the Engineering services function.
• Communicate operational status regularly to the appropriate Plant Leadership Team.
• Drive continuous improvement of site CQV and CSV strategy to meet increasing regulatory agency expectations.
• Lead plant process, utilities and cleaning CQV execution activities from identification of test criteria, generation of documentation, execution and release of the systems.
• Support ongoing operations by managing CQV execution support through the Change Control Process.
• Execute sustaining qualification / requalification plans.
• Lead the site Automation program ensuring all automation systems are validated and their validated status maintained throughout the lifecycle of the system.
• Ensure appropriate training of personnel on equipment, process and facility safety procedures is maintained.
• Coach personnel using effective performance reviews, training and development programs, setting and tracking goals and objectives.
• Motivate and develop staff to be leaders within Mallinckrodt.
• Actively influence and participate in the extended Plant Leadership Team.

Experience, Qualifications and Education Requirements

• Minimum degree level qualification in a related Engineering discipline or similar experience.
• Minimum 5 years relevant leadership experience in a cGMP commercial manufacturing environment.
• Demonstrated history of increasing job responsibility.
• Experience in leading large teams.
• Knowledge of current CQV best-practices, industry standards and regulator expectations.
• Experience of managing complex projects.
• Experience in the management of organizational change.
• Experience in working with best in class project management tools.
• Experience of budget preparations, control and management of finance spend.
• Experience in the effective use of structured problem solving tools, preferably with a formal qualification.
• Experience in the use of lean tools, preferably with a formal qualification.

Competencies / Preferred Skills

• Team leadership.
• Self-motivated and self-managing.
• Strong communication skills and the ability to perform effectively in a fast paced, multi-faceted environment.
• Ability to manage projects involving multiple functional groups without direct reporting authority.
• Organizational and operational agility, able to operate at all levels of the organization and able to shift priorities successfully.
• Able to identify, execute and prioritize work tasks / projects with an awareness of escalation responsibility as needed.
• Excellent facilitation and presentation skills.
• Conflict resolution and negotiation skills.
• Collaborative teamwork philosophy and demonstrated positive interaction with others.
• Mature judgment in problem solving situations.
• Independent decision-making abilities with strong results orientation mindset.
• Rigorous attention to detail.

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