Job Description
Job Summary: Experienced Validation Lead sought for a 12-month contract in Dublin, focusing on drug product process development, process improvement, and risk assessments in a GMP environment.
We are looking for a seasoned professional with 6 years of experience in a similar role, or a PhD with 3 years of experience, to lead our team in developing innovative solutions to complex challenges. The ideal candidate will have a strong background in process development, process design, and new product introduction.
Key Responsibilities:
Act as a technical expert in drug product process development, providing swift and innovative solutions to complex challenges in drug product formulation, vial filling, pre-filled syringe filling, lyophilization, and vial capping.
Lead continuous improvement projects to improve process performance and productivity, identifying and implementing operational opportunities for current and new sterile operations.
Perform process gap analysis and develop strategies to close gaps, conducting data trend analysis for all performance aspects of the area.
Troubleshoot performance trends and assess product impact associated with proposed changes to commercial processes under the change control process.
Review and approve changes to operating procedures, electronic batch records, and product documentation.
Collaborate with the new product introduction team, providing process subject matter expertise, including recipe development, protocol execution, and troubleshooting support.