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Associate, Manufacturing III - Ireland  

Company managed [?] Still accepting applications

Posted on : 19 June 2017

Project Description

Position Summary
Manufacturing Associate is responsible for performing manufacturing operations according to standard operating procedures and batch instructions under limited supervision.

 
Principal Responsibilities
  • Operate manufacturing equipment and instruments
  • Complete assigned tasks in a timely manner
  • Conduct daily activities in an organized, efficient manner
  • Perform simple, routine, complex, and critical operations
  • Troubleshoot equipment issues, when necessary
  • Ensure process equipment is appropriately maintained for operation
  • Perform and document operations in accordance with cGMP’s
  • Execute equipment qualification protocols and validation protocols
  • Routinely draft and revise standard operating procedures and master batch records
  • Recognize and initiate process deviations
  • Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved
  • Embrace company Core Competencies
  • Train other staff
  • Communicate effectively, written and verbal
  • Maintain training compliance
  • Ensure a safe working environment for all staff
  • Plan daily activities and schedule operations
  • Perform deviation investigations and closure
  • Interact with other departments
  • Perform data collection, compilation, and statistical analysis
  • Interact with vendors and outside resources
  • Complete assigned projects
  • Be the shift lead if required, providing instruction to the team
  • Troubleshoot and resolve operational problems during processing
  • Represent Manufacturing in cross functional initiatives and meetings
  • Monitor and evaluate process trends and recommend and implement continuous improvement strategies as appropriate
  • Manage multiple projects independently
  • Plan and implement complex changes
  • Perform Environmental monitoring as required.
  • Technical expert for entire area(s)
  • Interact independently with regulatory agencies
  • Develop and provide training on complex manufacturing processes
  • Perform Manufacturing review and approval of critical documents
  • Develop process validation protocols
  • Maintain good housekeeping and clean and sanitize classified areas as required.
  • Analyze complex problems and determine and implement solutions

 
Qualifications
  • Must be able to work within and adapt to complex electronic systems such as SAP and Trackwise
  • Must be able to read, write and converse in English
  • Must have good working knowledge of MS Excel and Word
  • Ability to work in an intense, fast-paced work environment
  • Ability to function, with guidance, in a rapidly changing environment while balancing multiple priorities simultaneously
  • Ability to work independently and as part of a team
  • More than 2 years experience in a cGMP biopharmaceutical manufacturing environment

 
Education
  • BA/BS in a scientific discipline or equivalent experience preferred.

 
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