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Maintenance Technician - Ireland  

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Posted on : 18 May 2017

Project Description

Description:
  • Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. 
  • Our company  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. 



Position Summary
  • We are also building our team to create a manufacturing culture of excellence in everything we do. We will deliver on time for our patients with the highest quality product.
  • The Level 1 / 2 Maintenance Technician is a hands-on member of a high performing, empowered shift team, responsible for the maintenance, repair and trouble-shooting of process equipment in the company Bulk Drug Substance (BDS facility). 
  • This position is also responsible for assisting in the co-ordination and scheduling of maintenance works performed by service vendors.
  • The role will initially be on days during the project / commissioning phase with a planned migration to the required shift pattern to align with production activities.

 

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.
  • Perform scheduled and unscheduled maintenance tasks in accordance with site policies and procedures.
  • Utilising and maintaining IT systems as required, e.g. Computerised Maintenance Management Systems.
  • Assist in writing and revising Maintenance job plans and SOP's for new equipment / processes as required.
  • Assist in the development of training materials for new equipment / processes as required.
  • Utilising structured troubleshooting and problem solving method to resolve equipment issues.
  • Support process safety and equipment related investigations / CAPA's.
  • Gathering and analysing process and operational performance data and leading operational process improvements. 
  • Complete training with new/junior Maintenance Technicians.
  • Seek and implement opportunities for Continuous Improvement.
  • Use Lean Tools as part of daily operations (Standard Work, 5S, Method 1, 2 etc.) to optimize efficiency and drive the culture of Continuous Improvement and Zero Defects.
  • Support Facility and Equipment start up and Validation activities. 
  • Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations.
  • Shift working is required. The shift pattern may be varied according to business requirements and will typically require weekend working and periodic rotation between day and night shifts.
  • Other duties as required.

 

 Qualifications
  • Experience performing maintenance on process equipment in a cGMP commercial manufacturing environment, preferably with experience working in a cleanroom environment.
  • Level 1 maintenance technician (1 – 3 years of relevant industrial experience).
  • Level 2 maintenance technician (3 years + of relevant industrial experience).
  • Familiar with biopharmaceutical equipment and systems such as bioreactors, centrifuges, autoclaves / glass washers, CIP, media/buffer systems, and purification systems.
  • Technical, troubleshooting and problem solving skills.
  • Proficient in use of Microsoft Office and other computer applications i.e. CMMS.
  • Good interpersonal and communication skills.
  • Must be knowledgeable of the regulatory and GMP requirements for maintenance activities.

 

Education
  • Degree/Diploma and/or technical certification / trade in a mechanical, electrical or related field.

 
 About Us: 
  • Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company  developed and commercializes 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, our company  is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.  
  • Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders 
  •  In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas