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Senior Technical Packaging Specialist

3 weeks ago

Dublin, Dublin City, Ireland beBeePackaging Full time

Packaging Engineering Specialist - A Challenging Role for Skilled Professionals.

The successful candidate will provide technical and engineering support for Finished Product (FP) manufacturing, including packaging engineering support throughout all phases of the product lifecycle, such as technology transfer, validation, and routine manufacturing. Key activities include providing technical support for biologics, small molecules, and medical device product packaging development at Contract Manufacturing Organizations (CMOs), supporting troubleshooting and deviation investigations with CMOs and internal teams, managing Change Controls and Risk Assessments related to Packaging Development, writing technical documents such as Packaging Tech Transfer Protocols, Technical Studies, and User Requirements Specifications, collecting and analyzing Packaging Development data, and supporting regulatory submissions for FP manufacturing processes.

Key Responsibilities:
  • Provide technical support for biologics, small molecules, and medical device product packaging development at Contract Manufacturing Organizations (CMOs)
  • Support troubleshooting and deviation investigations with CMOs and internal teams
  • Manage Change Controls and Risk Assessments related to Packaging Development
  • Write technical documents such as Packaging Tech Transfer Protocols, Technical Studies, and User Requirements Specifications
  • Collect and analyze Packaging Development data
  • Support regulatory submissions for FP manufacturing processes
Requirements:
  • Bachelor's degree in engineering or a related technical field, or equivalent experience in pharma or medical device packaging development
  • Knowledge of cGMP requirements for biopharmaceutical manufacturing
  • Strong communication skills for presentation and influence
  • Organized, detail-oriented analytical thinking
  • Excellent technical writing and communication skills
  • Proficiency in MS Excel, Word, PowerPoint
  • Experience with GMP systems such as Change Control and Document Management
  • Familiarity with Project Management principles and tools, including MS Project
  • Experience with Risk Assessment in a cGMP environment

If you are a skilled professional looking for a challenging role that utilizes your technical expertise and experience in packaging engineering, this could be the ideal opportunity for you.