Manufacturing Specialist

  • Contract
  • Dublin

Website Ref:TPM04310

Summary:
A Manufacturing Specialist is required for a biopharmaceutical company in South Dublin. The Manufacturing Specialist will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations.

Responsibilities:

  • 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 & Experience:

  • Bachelor’s Degree in Science or Engineering.
  • 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 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.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.