Manufacturing Specialist – ref 130MQ

Website HeadcountGroup Headcount Solutions

Headcount Solutions is seeking a Manufacturing Specialist (Investigation Lead) for our client’s biotech facility in Dublin. This person 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.
  • Able to apply inductive and deductive reasoning in the investigation process.

Requirements:

  • 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) OR * Associate’s Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) * 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment.
  • 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 in managing multiple, competing priorities in a fast-paced environment.
  • Experience presenting to inspectors during regulatory inspections and internal audits.
  • Excellent presentation and communication skills, ability to communicate and collaborate with technical and management staff.

For further information please contact Mick on 086-0435195 or forward details in confidence to [email protected]

 

Name
Email
Telephone
Message
Upload your CV/resume or any other relevant file. Max. file size: 256 MB.
Check the box to confirm our use of your data under GDPR regulations. To register your CV you must tick the checkbox to confirm your acceptance of our GDPR and Privacy Policy