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Engineering Planner - Ireland  

Company managed [?] Still accepting applications

Posted on : 18 May 2017

Project Description

 

 

Engineering Planner

 

Reports to:

Engineering Lead

Location:

College Park

Global Level:

Level 7

 

 

Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. Alexion is also establishing a premier global metabolic rare disease franchise, which includes Kanuma™ (sebelipase alfa) for patients with lysosomal acid lipase deficiency (LAL-D), and Strensiq™ (asfotase alfa) for patients with hypophosphatasia (HPP). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas. As the global leader in complement inhibition, the Company is strengthening and broadening its portfolio of complement inhibitors across diverse platforms, including evaluating potential indications for Soliris in additional severe and ultra-rare disorders. Further information about Alexion can be found at: www.alexion.com.

Position Summary

 

The Engineering Planner is responsible for the operation and administration of the site Computerised Maintenance and Calibration System. This position is also responsible for the planning and scheduling of all planned and unplanned maintenance and calibration works performed on the Dublin site, including works performed by external service providers.

The individual in this position is expected to represent Alexion Pharmaceutical interests, objectives and policies in a professional and responsible manner.

 

Principal Responsibilities

 

  • Complying with the Maintenance and Quality System by adherence to all relevant SOP's, policies and cGMP requirements.
  • Proactively ensuring that all Environmental, Health and Safety responsibilities are carried out according to EHS regulations and procedures.
  • Maintaining the Maintenance and Calibration Quality System by adherence to all relevant SOP’s, policies and cGMP requirements.
  • Act as a subject matter expert on the site CMMS, Infor EAM.
  • Develop, issue and maintain key performance metrics for the Facilities & Maintenance department.
  • Lead for planning all scheduled and unscheduled maintenance and calibration tasks in accordance with site policies and procedures.
  • Proactively ensuring that all Environmental, Health and Safety responsibilities are carried out according to EHS regulations and procedures.
  • Optimise – by working with the Maintenance & Calibration Technicians – the effectiveness of preventative maintenance and calibration programs.
  • Lead for maintaining spare parts, change parts and test equipment for the site in the Engineering Stores.
  • Ensure the Maintenance and Calibration Management System is maintained correctly.
  • Act as a subject matter expert during regulatory inspections and internal audits.
  • Lead the writing and revising of relevant Maintenance & Calibration SOP’s as required.
  • Provide support to new equipment installations and product introductions.
  • Filing and archiving of Facilities and Maintenance documentation.
  • Provide support to Operations, Validation, Engineering and Quality where required.
  • Complete training on CMMS with relevant personnel as required.
  • Develop and maintain strong meaningful relationships with counterparts in other Alexion manufacturing sites in order to maintain high levels of skill and technical knowledge.
  • Seek and implement opportunities for Continuous Improvement.
  • Use Lean Tools as part of daily operations (Standard Work, 5S, Method 1, 2 etc.)
  • Other duties as required.

 

 

Qualifications

  • Min 2-3 years, exposure in Maintenance, Facilities or General Engineering
  • Knowledge / Exposure to Calibration
  • Problem Solving skills – demonstrated ability in the use of scientific methodology to problem solve.
  • 2-4 years’ experience working within a facilities, maintenance and calibration environment in a cGMP commercial manufacturing environment.
  • Experience in performing calibration support activities would be an advantage.
  • Prior experience with CMMS and Computerised Calibration Systems.
  • Good interpersonal, communication and problem solving skills.
  • Must be knowledgeable of the regulatory and GMP requirements for maintenance activities, instrumentation and calibration.

 

 

Education

  • Degree and/or technical certification in a mechanical, electrical or related field is required.

 

 

As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.

*LI-CH1 

 

Dublin, Ireland
 

 

Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.