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Global Engineering Intern - Ireland  

Company managed [?] Still accepting applications

Posted on : 25 April 2017

Project Description


 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,  to treat patients. 
  • 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.

 

Position Summary 
  • To assist the Validation Team to prepare the necessary documentation and monitor progress for technical projects across the organization.   
  • The incumbent will be a contributor in supporting the execution of the company’s plans and maintaining the company’s position as a knowledge leader in the bio pharma industry.

 

Specific Accountabilities:
  • Document coordinator support for Phase 1 and Sustaining Project support
  • Developing a playbook (per system) listing the qualification documents generated during system qualification lifecycle
  • Developing the ADMF Sustaining Projects SharePoint site
  • Maintaining hardcopy records in Document control archive,  including reconciliation of Document tracker.
  • Developing library of softcopy versions of all Validation documents
  • Maintaining / Updating the Training Matrix for Validation / Automated Teams
  • Supporting closeout of TrackWise actions for Validation team
  • Coordinating a Validation dashboard update for site management / leadership
  • Supporting the close-out of the CCC (Care, Custody, Control) forms for qualified systems / equipment
  • Completing minor updates on SOPs e.g. from periodic reviews of procedures
  • Provide support in areas of commissioning and operation of mechanical, process, electrical, automation equipment and systems and performance test protocols.
  • Prepare technical operating procedures.
  • Participate in feasibility studies for proposed equipment, systems or processes.
  • Coordinate and meet with project teams to discuss requirements and constraint issues.
  • Coordinate and conduct task reviews to ensure alignment with technical requirements and specifications.
  • Prepare preliminary project reports and update daily activities for management review.
  • Maintain current records for each project.
  • Report / present out on project updates as required
  • Perform other duties as assigned. 

 

Minimum Knowledge and Skills Required Performing the Job:
  • Engineering or Science based Degree.
  • Basic knowledge of concepts, principles and practices of engineering.
  • Basic Project management and organizational skills.
  • Good verbal and written communication skills.
  • Ability to read, interpret technical documents.

 

Education
  • Junior level standing or higher in Engineering / Science course work leading to an Engineering / Science degree from an accredited xx-year college or university.


Competencies
  • Ability to perform assigned tasks and complete work on schedule with minimal supervision.
  • Eagerness to learn and accept challenges
  • Able to handle multiple tasks
  • Good communication skills
  • Working knowledge of computer programs (Microsoft Word, Excel, Outlook)