Process Engineer
Role: Process Engineer Contractor – (Cell therapy/ gene therapy/GMP)# 1013053Location: Cambridge, MAWork Schedule: Onsite 5 days/weekDuration: 12+ month contractPay Rate: $85–$90/hour Key ResponsibilitiesProvide engineering expertise for the design, selection, specification, and lifecycle management of cell and gene therapy process equipment and manufacturing systems.Own equipment and system activities through requirements definition, design reviews, commissioning, qualification, validation, and ongoing manufacturing support.Drive process improvements focused on equipment reliability, scalability, robustness, and operational efficiency.Support engineering projects including URS/FRS development, technology evaluations, risk assessments, FMEA, FAT/SAT execution, technology transfer, and validation activities.Troubleshoot manufacturing equipment issues and provide technical support to enable sustainable solutions.Develop and review technical documentation including protocols, reports, SOPs, work instructions, and engineering assessments.Lead and support deviation investigations, root cause analysis, CAPA development, and change control activities.Collaborate with Manufacturing, Quality, Validation, Facilities, MSAT, Process Development, Project Management, and external partners.Apply engineering best practices and continuous improvement methodologies to enhance manufacturing capabilities.Required QualificationsBachelor’s or Master’s degree in Engineering or related technical discipline.7+ years of relevant experience with a BS or 5+ years with an MS in process engineering, equipment engineering, systems engineering, or process optimization.Experience supporting GMP-regulated manufacturing environments.Experience with equipment design, commissioning, qualification, validation, and lifecycle management.Experience in cell therapy, gene therapy, biotechnology, or advanced manufacturing preferred.Strong understanding of cGMP/cGxP requirements and regulated manufacturing practices.Experience with:21 CFR Part 210/211Equipment qualification and validationFMEA and risk assessmentsRoot cause analysisCAPAChange controlPreferred QualificationsLean/Six Sigma or DMAIC experience.Strong technical writing and communication skills.Ability to manage complex projects and influence cross-functional teams.Strong problem-solving skills with the ability to work independently in a fast-paced environment.Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status