Job Title

Maintenance & Calibration Lead

Requisition

JR000014054 Maintenance & Calibration Lead (Open)

Location

College Park, Dublin - IRL006

Additional Locations

Job Description

Summary

Reporting to the Site Engineering Manager, the Maintenance and Calibrations 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.

• Provide SME support and participate in regulatory inspections.

Essential Functions

• The position requires effective cross-functional collaboration with internal partners including Site Engineering, Facilities Management, Engineering Services, 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 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 and participate in the on call process when rostered with oversight and responsibility for all site activities out of hours.

• Management of the calibration program and calibration service provider onsite.

• Act as the instrumentation owner with accountability for the calibration program.

• Maintain a working and in-depth knowledge of products, calibration techniques and procedures

• Coordinate completion of all planned calibration/electrical and repair work with Manufacturing and Engineering to ensure manufacturing schedules are met

• Schedule calibration and repair work performed by external vendors with appropriate functional areas.

• 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.

• 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.

• Performing other duties as required.

Minimum Requirements

Education / Experience / Skills:

• A third level degree in Engineering or working towards it or similar experience.

• Minimum of 5 years relevant experience working in a technical engineering 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.

• 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.

Organizational Relationship/Scope:

Reporting to the Site Engineering Manager.

Working Conditions:

As per standard contract and Dublin College Park attendance and Timekeeping Policy and Hybrid Working Policy - Dublin College Park

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.

To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.

Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.