Principal Process Engineer

Requirements:Bachelor's Degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.10+ years of experience in bioprocess engineering within the biotech or biopharmaceutical industry.Pluses:Master's Degree in related field.Job Description:Principal Process Engineering is responsible for all Manufacturing process equipment and ensures the equipment and site infrastructure is in an active state to support cGMP operations. As a Principal Process Engineer, you will act as member of a cross-functional team to support implementation of new systems and improvements to existing manufacturing processes and equipment. You will apply sound scientific and engineering principles to successfully define upstream and downstream process equipment requirements, specifications and standards for facility fit, and assess equipment design and operation in a commercial cGMP production facility. This may include upstream activities such as cell culture and harvest, and/or downstream processes such as chromatography, purification, and filtration. You will be at the forefront of existing best practices and evaluating technologies. Provide system ownership for Upstream Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of process equipment.Key Responsibilities:You will support equipment commissioning and qualification activities related to new or modified processes.Collaborate with MS&T and Manufacturing teams to troubleshoot and resolve equipment and process-related issues in manufacturing systems.Act the technical subject matter expert (SME) for upstream and/or downstream equipment and the site clean utilities ensuring proper installation, qualification, and maintenance of these systems.Lead process engineering related projects to improve manufacturing operations or implementation of new processing equipment. As the project lead you will ensure on time delivery, compliance with project requirements, and project budget.Lead the development, scale-up, and optimization of upstream (cell culture, fermentation) and/or downstream (purification, filtration) processes for biologics or advanced therapiesDesign and execute experiments to improve process robustness, yield, and product qualityCollaborate with Engineering, Quality, Regulatory, and Manufacturing teams to ensure seamless tech transfer and GMP complianceAuthor and review process documentation including SOPs, and Engineering Studies protocolsServe as a technical lead in cross-functional project teams and represent process engineering in regulatory filings and auditsEvaluate and implement new technologies (e.g., single-use systems, PAT tools, continuous processing) to enhance scalability and efficiencySupport capital projects including facility design, equipment selection, and commissioningLead risk assessments, and root cause investigations for process deviationsCommunicate with other KBI sites for problem solving and consistency of processes through the organization.Contribute to developing a culture of continuous improvements on processes and tools in close collaboration with other.You will perform facility fit activities for various production scenarios.You should be able to apply engineering principles in-order to problem-solve and drive projects to successful completion within defined timelines.The ability to manage multiple concurrent projects and resources.Lead and support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems.Providing technical support for equipment modifications, deviations, change controls, and CAPAs.Develop and maintain equipment SOPs (Standard Operating Procedures), training, and other process documentation.