Proclinical is seeking a ProcEng to join the team in support of day-to-day functions and constant improvement in pre-filled syringe processes.
Responsibilities:
Act as Process Engineer for projects related to pre-filled syringe operations.
Develop filter tests and fill weight cycles.
Conduct cleaning verification and generate necessary documentation such as recipe documents, FMEAs, protocols, and reports.
Lead problem-solving investigations and manage change controls.
Ensure activities are completed on schedule and within budget.
Support syringe filling operations through investigations and corrective actions.
Communicate with material/component vendors during projects.
Execute Process Engineering activities in compliance with safety standards.
Write Process/Operational Control Strategy documents and support operator training.
Coordinate project deliverables to meet timelines and costs.
Generate schedules for planning and execution of deliverables.
Provide support for existing Aseptic Syringe Filling Line and related processes.
Contribute to commercial manufacturing by delivering key performance metrics.
Participate in site GMP regulatory and safety audits.
Offer technical support for process improvements and new product transfers.
Key Skills and Requirements:
Honours degree in an Engineering discipline.
Strong problem-solving skills.
Experience in a highly regulated GMP environment.
Advantageous experience in Sterile Manufacturing Operations and syringe filling.
Experience in new product introduction is beneficial.
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