Excellent opportunity for a Formulation Engineer to join a Leading Biologics company focusing in Drug Products in Vaccines production. The Drug Product Engineer will ensure the safe and compliant operation of the Drug Product Manufacturing facility. Under the guidance of the DP Engineering Lead, you will spearhead technical initiatives, drive process enhancements, and collaborate with cross-functional teams to maintain equipment and processes at their validated state.
Overview of your responsibilities (full job description available on request)
Assume technical leadership in a state-of-the-art Vaccine Drug Product Manufacturing facility.
Oversee installation of equipment adhering to industry standards.
Review and contribute to the creation of testing protocols, reports, and manufacturing SOPs.
Lead Commissioning & Qualification activities for new equipment.
Create and execute documentation for risk assessments and CQV protocols/reports.
Manage Equipment Vendors, including SAT execution, on-site maintenance visits and continuous improvement
Support equipment validation through the execution of revalidation protocols.
Knowledge, Skills and Experience Required for the Role:
Bachelor of Engineering or Science Degree in an Engineering or Technology-related discipline.
Specific experience with Autoclaves, Parts Washers, and CIP/SIP equipment.
Familiarity with Formulation processes and filling machines.
Minimum of 5 years of cGMP industrial/engineering experience.
Proficiency in executing on-the-floor activities such as FAT, SAT, IQ/OQ.
Experience applying a risk-based approach to manufacturing using tools like FMEA.
For a confidential discussion and more information on the role contact Courtney Russell
+353 (0) 71 9108062