Site Engineering Lead

at Mallinckrodt Pharmaceuticals
Location College Park, Maryland
Date Posted September 19, 2022
Category Engineering
Job Type Permanent


Job Title

Site Engineering Lead


JR Site Engineering Lead (Open)


College Park, Dublin - IRL006

Additional Locations

Dublin, IRL

Job Description

Reporting to the Site Engineering Manager, the engineering lead is primarily responsible for the

Reliability of all engineering assets onsite providing maintenance and calibration support in all areas.

Management of maintenance team including technicians assigned from facility management contractor.

Dedicated owner and SME for all equipment external to the clean areas.

Management of E&I department including the calibration program and engineering safety programs.

Provide SME support and participate in regulatory inspections.

The position requires effective cross-functional collaboration with internal partners including Site Engineering, Facilities Management, Manufacturing Operations, Technical Operations, and Quality and external contractors.
Ownership and tracking of engineering key performance indicators (KPI's) for all associated areas.
Manage all maintenance engineering activities and utility activities to meet and optimize manufacturing schedules while maintaining a high level of GMP compliance and cost efficiency.
Manage maintenance activities including all planned and unplanned works on equipment and the management of the maintenance program activities in these areas.
Manage utility equipment activities includes all planned and unplanned works on utility equipment in CPMF and Admin/GDE and the management of the maintenance program activities in these areas.
Manage preventative maintenance schedule and prioritising maintenance technician works across process and utility equipment.
Cross train the process and utility technicians to utilise the available resources to work in multiple areas.
Manage and optimise the preventative maintenance program across process and utility systems including a review of executed maintenance activities and identify improvements to the maintenance job plan content.
Manage and implement equipment and maintenance reliability improvements. Development and implementation of area / equipment improvement plans to repeat failures and other maintenance problems.
Manage on-call process for engineering.
Manage E&I Engineer and his associated responsibilities for the calibration program.
Sponsor engineering safety programs within the maintenance and utilities structure including Hazardous energies, Electrical safety, ATEX, Confined Space, NDT/Insurance Inspections, Pressure equipment directive
Delivery of engineering commitments on regulatory programs associated with these assets including AER, EPA, HSA, ISO certifications.
Provide support to Manufacturing, Validation, and Maintenance on process equipment and utility systems when required.
Provide Engineering expertise in trouble shooting activities to support manufacturing during process transfer activities or deviation investigations.
Provide support and participate in regulatory inspections.
Lead and support system improvements, development of specifications, engineering documents and standard operating procedures.
Identify and support process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing support equipment.
In conjunction with approved vendors, research new processes and/or systems for maintenance/manufacture of equipment and implement new processes and systems as developed under the direction of the Operations Manager.
Acts as an advocate for engineering continuous improvement activities.
Ownership of equipment/systems in a GMP regulated manufacturing setting.
Ownership and tracking of engineering key performance indicators (KPI's) for the maintenance and utility areas.
Take the lead in troubleshooting and problem solving on process equipment while providing coaching and mentoring to other engineering, maintenance and operations staff.
Lead technical root cause analysis, incident investigations and troubleshooting issues related to utility equipment/systems.
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
Promote regulatory compliance and alignment of the site with the Business Unit Engineering strategies and objective.
Ensure a commitment to safety, quality and operational excellence at a competitive cost. Understand system reliability and availability and manage any scheduled or unscheduled down-time and the associated risk.
Improving the engineering programs compliance, performance and reliability through technical knowledge and people leadership.
Improving the validated equipment systems compliance, performance and reliability through technical knowledge and people leadership.
Identifying and justifying improvement projects.
Performing other duties as required.

Experience, Qualifications and Education Requirements

A third level degree in Engineering - Process, Mechanical, Electrical or similar discipline
Minimum of 10 years relevant experience working in a technical engineering management role in the Pharmaceutical / Biotechnology industry.
Evidence of continuous professional development.
Team leadership experience.
Experienced in identifying priorities for assignment of resources and time.
Experienced in the application of lean principles and structured problem-solving techniques.

Competencies / Preferred Skills

Strong technical capabilities, communication skills, teamwork abilities and initiative.
Demonstrated ability to work effectively with vendors and resolve issues in a timely and structured manner.
Organized analytical thinker with strong attention to detail
Excellent oral and written communication skills, including technical writing
Demonstrated ability to work effectively with vendors and resolve issues in a timely and structured manner.
Must have good verbal and written communication skills. Ability to present and explain data to both technical and non-technical forums.
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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