The Role
We are recruiting for a Manufacturing Specialist Investigations Lead to be based in Dun Laoghaire on a 12-month initial contract. This is a hybrid role.
Key Responsibilities
* Good technical writing skills for all deviation incidents, ensuring a thorough write-up of events.
* Project management skills for every deviation incident, managing timelines and expectations effectively.
* Strong Communication skills, leading cross-functional teams who may not have technical knowledge, requiring the ability to ask the right questions and gather relevant information.
Description
The Manufacturing Specialist (Investigation Lead) will primarily lead investigations for fill/finish/inspection and packaging deviations. Specialists will also apply process, quality, compliance, and analytical knowledge to:
* Closely coordinate and lead cross-functional teams through complex investigations, completing tasks on-schedule.
Requirements
* Bachelor's Degree in Science or Engineering, with 5+ years of directly related experience in biotech/pharma manufacturing or manufacturing support roles (process development, engineering, quality).
* Associate's Degree in Science or Engineering, with 8+ years of directly related experience in biotech/pharma manufacturing or manufacturing support roles (process development, engineering, quality), or 10+ years directly related experience in a biotech/pharma manufacturing environment.
* Detailed technical understanding of fill/finish operations.
* Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems.
Preferred Qualifications
* Experience leading complex investigations.
* Participating in and leading cross-functional teams.
* Managing multiple, competing priorities in fast-paced environments.
* Presenting to inspectors during regulatory inspections and internal audits.