Senior Process Engineer Position Available In Suffolk, Massachusetts

Join to apply for the Senior Process Engineer role at Katalyst CRO 2 days ago Be among the first 25 applicants Responsibilities This role is responsible for providing technical support regarding the execution of 4 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). Understand engineering drawings, SOPs, vendor documentation, and other technical documentation. Manage assigned projects and initiatives efficiently and effectively. Assist Senior and Principal Engineers on more complex projects/initiatives as required. Requirements Bachelor’s degree in engineering or equivalent field. 6 to 10 years of role-specific experience required. Advanced experience executing pFMEAs, PPQs, and assessing and reporting on 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 production areas (CNC space, ISO classified rooms, grey space). Knowledge of product flow through various production areas. Strong understanding of process fundamentals and qualification/validation requirements for small molecule chemical synthesis, monoclonal antibody or protein biomanufacturing, cell therapy and regenerative medicine, sterile drug product fill/finish, analytical QC laboratories, computer systems, and packaging. Ability to communicate concisely with senior management. Advanced Microsoft Project capabilities. Familiar with regulatory audit processes and capable of assessing supporting documents. Proficient in MS Office applications. Willingness to travel to various sites, including overseas.

Additional Details Seniority level:

Mid-Senior level Employment type: Full-time Job function:

Management and Manufacturing Industries:

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