Senior Process Engineer Role
This is a unique opportunity to work with an industry-leading pharmaceutical client in Ireland.
The company has the largest veterinary vaccine development and production centre worldwide, employing over 1000 people. They are seeking a Senior Process Engineer to join their team and be involved in critical investment projects both on-site and remotely.
Key Responsibilities
1. Collaborate with external partners to achieve business goals and foster a common culture that benefits all parties involved.
2. Lead technical activities for commercial manufacturing processes at external partners, including change control authorship, process improvement project management, statistical analysis of process performance, and investigation of atypical events.
3. Oversee technical transfer activities, as applicable, through the creation and/or review of GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
4. Provide on-site support at external partner locations in conjunction with Commercial and/or Technology Transfer Person-In-Plant Activities.
5. Translate understanding of GMP requirements and current regulations into standardized work practices by partnering with Operations, Quality, and external partners.
Favourable Qualifications
* Previous experience with fill finish Pre-Filled Syringe operations is essential for this role.
* A Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or a related field is required.