Job Summary
We are seeking a highly skilled Biopharmaceutical Process Specialist to join our team. As a key member of our operations team, you will be responsible for ensuring the smooth execution of sterile manufacturing operations and new product introductions.
The ideal candidate will have 3+ years of experience in a highly regulated GMP environment, with a strong understanding of process engineering principles and sterile manufacturing operations. They will also have excellent problem-solving skills, a keen eye for detail, and the ability to work effectively in a fast-paced environment.
Key Responsibilities:
* Support day-to-day operations of the syringe filling area through investigations, identify and deliver corrective actions, including continuous improvement projects.
* Communicate and liaise with material/component vendors during project.
* Execute Process Engineering activities to schedule and to the appropriate compliance and safety standards.
* Writing of Process/Operational Control Strategy documents (detailing control over Critical Process Parameters), Failure Mode Effect Analysis (FMEA) and supporting Operator training.
* Coordinating and ownership of deliverables to meet project timelines and cost.
* Generation of hour-by-hour schedules for planning line time and execution of deliverables.
* Provide support where required on the existing Aseptic Syringe Filling Line and supporting processes which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
* Support commercial manufacturing through delivery of key performance metrics (SQDCI).
* Role may require travel to other sites or vendor sites.
* Participate in site GMP regulatory and safety audits.
* Provide technical support to implement process improvements, new product transfers to the site and production.
Requirements:
* Honours degree in an Engineering discipline.
* Strong problem-solving skills.
* 3 or more years' relevant experience in a highly regulated GMP environment.
* Experience of Sterile Manufacturing Operations would be an advantage.
* Experience in syringe filling would be a distinct advantage.
* Experience in new product introduction would be a distinct advantage.