Senior Process Engineer

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Responsibilities: This role is responsible for providing technical support regarding the execution of Process Performance Qualifications (PPQ) by visiting the tech transfer receiving sites and evaluating the current state of operational readiness through the execution of pFMEA for each site. Develop and execute current state operational readiness assessment pFMEAs. Report findings with recommendations and escalate critical risks/gaps identified timely. Support resolution of identified gaps, identifying root causes and defining. corrective/preventive actions with equipment, processes and automated systems Possess demonstrated technical skills and knowledge with biopharmaceutical operations specifically Monoclonal Antibody (Manufacturing). Possess understanding of engineering drawings, SOPs, vendor documentation, and other technical documentation. Efficiently and effectively manage assigned projects and initiatives. As required by group, assist Senior and Principal Engineers on more complex projects/initiatives. Requirements: Bachelor's degree in engineering or equivalent field. to years or role specific experience required. Advanced experience executing pFMEAs, PPQs and assessing and reporting on the current state of Operational Readiness. Ability to assess and report on process validation activities involving cross-functional teams including Manufacturing, Process Sciences, Process Development, Quality Control. Quality Assurance, Regulatory Affairs, and others. Comfortable walking through all areas of the production module (CNC space, ISO classified rooms, grey space).Knowledge of the product flow through the various production areas. Strong Understanding of process fundamentals and qualification/validation requirements for the following: Small molecule chemical synthesis. Monoclonal antibody or protein biomanufacturing. Cell therapy and regenerative medicine. Sterile drug product fill/finish. Analytical QC laboratories. Computer System. Packaging. Ability to interact directly and communicate concisely with senior management. Advanced Microsoft Project capabilities. Familiar with regulatory audit process and capable of assessing provided supporting documents. Proficient in computer skills and MS Office applications. This role will be traveling to various sites, with some overseas travel required.
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Location:
Boston

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