The Role
PE Global is recruiting for a Manufacturing Specialist Investigations Lead to be based in Dun Laoghaire, with an initial 12-month contract. The role is hybrid, requiring good technical writing skills for all deviation incidents and the ability to manage timelines and expectations.
Key Responsibilities
* Leading investigations for fill/finish/inspection and packaging deviations
* Applying process, quality, compliance, and analytical knowledge to complete investigations
* Managing deviation investigations, including establishing investigation teams and leading root cause analysis
* Developing CAPAs and completing product impact assessments
* Writing comprehensive, compliant documentation of all findings
Requirements
* Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role
* Or Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role
* 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment
Skills
* Detailed technical understanding of fill/finish operations
* Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems
* Excellent technical writing and presentation skills
* Ability to communicate and collaborate with technical and management staff
Company Culture
At PE Global, we are committed to providing a supportive and inclusive work environment. We believe in the importance of building effective relationships across functions and navigating through ambiguity to provide a structured problem-solving approach.