Role Overview
We are seeking a highly skilled bioprocess engineer/technical writer to serve as the technical subject matter expert (SME) to standardize equipment strategies. The successful candidate will be pivotal in ensuring GMP compliance, leading multidisciplinary teams, and driving technical documentation excellence.
Key Responsibilities
Develop and implement the standardization equipment strategy.
Serve as the technical SME for upstream (USP) perfusion systems, downstream (DSP) single-pass TFF, and Ross fill systems.
Act as the manufacturing expert in capital investment projects for building and commissioning manufacturing units.
Design, update, and manage GMP-compliant SOPs and technical operations documentation with precision and timeliness.
Review and approve project deliverables on behalf of Operations, ensuring compliance with regulatory standards.
Lead efforts to manage change requests (CRs), deviations, and corrective actions/preventive actions (CAPAs).
Represent Operations during audits as the SME for disciplines under scope.
Utilize tools such as DeltaV/Syncade, DMS, Trackwise, Kneat, and LIMS to streamline operations.
Education & Experience
Master’s or Bachelor’s degree in Biotechnology, Biochemical Engineering, or related Life Sciences field.
3–5 years of experience in biomanufacturing with expertise in mammalian cell culture processes.
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