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Ruth Holland
Life Science

01 507 9255
[email protected]
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Details

Manufacturing Specialist


Reference:RH/10052022 Location: Dublin South
Qualification:DegreeExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Manufacturing Coordinator

Life Science Recruitment are recruiting for a Manufacturing Specialist to join the team with our Biopharmaceutical client based in South Dublin. It’s is a 23 month hybrid contract role – current split 2 days on site and 3 days from home.



The Manufacturing Specialist (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge to complete the following:

  • Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing compliant documentation of all findings.
  • Clear and concise technical writing of complex investigations
  • Drive improvements to the investigation process
  • Present investigations to regulatory inspectors and internal auditors
  • Clearly communicate investigation progress to impacted areas and leadership
  • Coordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule.
  • Project management of the investigations end to end
  • Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
  • Build effective relationships across functions.
  • Navigate through ambiguity and provide a structured problem-solving approach.
  • Able to apply inductive and deductive reasoning in the investigation process


Qualifications:
  • Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality)
  • Detailed technical understanding of fill/finish operations
  • Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.
  • Experience leading complex investigations
  • Experience participating in and leading cross-functional teams
  • Experience in managing multiple, competing priorities in a fast-paced environment
  • Experience presenting to inspectors during regulatory inspections and internal audits.
  • Excellent technical writing
  • Excellent presentation and communication skills, ability to communicate and collaborate with technical and management staff
  • Ability to be flexible and manage change
For more information contact Ruth Holland on 087 7822198 [email protected]