Manufacturing Specialist (Investigations Lead)
LSC offers a great contract opportunity for a Manufacturing Specialist (Investigations Lead) to join a South Dublin-based Biopharmaceutical company specializing in secondary manufacturing activities such as formulation, fill finish, and packaging.
About the Role
The successful candidate will be responsible for managing deviation investigations, including establishing investigation teams, leading root cause analysis, developing corrective actions, completing product impact assessments, and writing compliant documentation of all findings.
Key Responsibilities:
* Clear and concise technical writing of major deviation investigations
* Drive improvements to the investigation process
* Present investigations to regulatory inspectors and internal auditors
* Clients communicate investigation progress to impacted areas and leadership
* Coordinate and lead cross-functional teams through major deviations, and complete tasks on-schedule
About You
We are looking for a highly skilled individual with a Bachelor's Degree in Science or Engineering and 3+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (e.g., process development, engineering, quality).
Alternatively, candidates with an Associate's Degree in Science or Engineering and 5+ years of directly related experience may also be considered.
Requirements:
* Technical understanding of fill/finish operations
* Experience leading investigations/deviations/non-conformances
Benefits:
* Work from home
Please note that applicants must be eligible to work in Ireland, holding a Stamp 1 G/Stamp 4 visa to apply.