The Process Engineer (PE) has the responsibility to:Author and review GMP documentation, for example:Standard Operating Procedures (SOPs)Batch record modulesTechnical Protocols, reports, or position papersExecutable batch recordsProvide support to the process team in the formulation and filling of clinical liquid drug product supplies.PE support includes (but is not limited to): pre-execution readiness activities (label generation, generating summary of components & assemblies required for manufacture, authoring or issuance of batch documentation), sample delivery, and clinical product delivery.Review executed batch documentation for adherence to good manufacturing practices and batch instructionOwn change control records for equipment or process changes; PE must effectively collaborate with stakeholders to assess impact, identify deliverables, and manage change implementation.Perform deviation management, including authoring of events, assessment of impact, investigation of root cause, and identification of corrective & preventative actions.Drive process improvement projects in documentation, knowledge management, or shopfloor related activities.Qualify for aseptic gowning, as required per assigned work. This role is on-site 5 days/week
