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.
- 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 firstname.lastname@example.org.