Process Data Monitoring Manager

  • Type: Permanent
  • Location: Limerick
  • Salary: Negotiable
  • Job Ref: PDM090118
  • Date Posted January 9, 2018

We are currently recruiting for a Process Data Monitoring Manager to join a leading pharmaceutical company based in Limerick. This is a full-time, permanent position and is offering an excellent salary and benefits package.

Summary: Supports the Process Monitoring team through leading the area of process performance monitoring. To establish, organize and maintain the in-process-controls process performance monitoring program and supporting manufacturing activities.

Essential Duties and Responsibilities:

  • Lead the team that champions the process performance monitoring program, and manage all activities to assure that manufacturing processes are supported
  • Manages routine process monitoring activities including data entry, statistical analysis, cross-functional data review and issuance of trend reports and plans.
  • Responsible for ensuring verified process data is available and easily accessible.
  • Apply statistical process control to clinical and commercial process data to enable decision making
  • Presents and reviews process performance monitoring data to IOPS Management as necessary
  • Work with cross-functional departments to ensure process data is being used to maximize process understanding and knowledge sharing initiatives.
  • Ensures compliance with regulations and regulatory guidance.
  • Develops, coaches, and provides leadership within the process monitoring team.
  • Assists in troubleshooting activities associated with the manufacturing process that involves data analysis
  • Ensure information requests for data from the IOPS site is provided in an accurate, complete, and timely manner
  • Involve the correct subject matter experts (SMEs) to answer detailed information requests and help troubleshoot unexpected process performance.

Education and Experience:

  • BS/MS in related field and 5-10 years of relevant industry experience and previous supervisory experience; equivalent combination of advanced education and experience may be considered.
  • Ideal candidate has experience in biologics drug substance (DS) manufacturing and technology transfer.

For more information on this position please call Lee-Ann Enright on 061336136 or apply online and a member of the Harmonics team will be in touch

More Details

Fore more information on this position please call Lee-Ann Enright on 061336136 or apply online and a member of the Harmonics team will be in touch

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