**Job Title:** Process Engineer
We are seeking a highly skilled Process Engineer to support our pre-filled syringe processes within a sterile manufacturing environment. The successful candidate will focus on continuous improvement, technology transfer, and capacity enablers for monoclonal antibody (mAb) commercial products.
Key Responsibilities:
* Act as Process Engineer for projects related to pre-filled syringe operations.
* Develop and execute filter tests, fill weight cycles, and cleaning verification activities.
* Generate and execute documentation such as recipe documents, FMEAs, protocols, and reports.
* Lead investigations and manage change controls to resolve technical issues.
* Ensure activities are delivered on schedule and with quality.
* Support daily operations in the syringe filling area and implement corrective actions for continuous improvement.
* Collaborate with material/component vendors during projects.
* Write Process/Operational Control Strategy documents and support operator training.
* Create hour-by-hour schedules for planning line time and execution of deliverables.
* Provide technical support to implement process improvements and new product transfers.
* Participate in GMP regulatory and safety audits.
Requirements:
* Honours degree in an Engineering discipline.
* 3+ years of relevant experience in a highly regulated GMP environment.
* Experience in sterile manufacturing operations is an advantage.
* Experience with syringe filling processes is a distinct advantage.
* Experience in new product introduction is preferred.
* Strong problem-solving skills.