Senior Process Engineer - Large Molecule

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a global pharmaceutical manufacturing client in Wilson, NC. No Third-Party, No Corp to Corp, No Sponsorship Now, Future or Temporary Authorization Senior/Principal Engineer – Large Molecule Drug Substance (LMDS)Pay Rate: $72.40/hr (w2) Location: Wilson, NCContract: 24 months Travel: Domestic travel up to 10% (primarily annual project/site support)Position SummaryWe are seeking a senior-level engineering leader to support the design, start-up, and operational readiness of a GMP large molecule biologics manufacturing facility. This role will provide advanced process and manufacturing engineering expertise across equipment, utilities, automation, and facility systems supporting technology transfer, CAPEX projects, and manufacturing start-up activities. The ideal candidate brings deep biologics drug substance experience, proven GMP facility start-up leadership, and the ability to drive complex engineering projects from design through commissioning and operational handoff.ExperienceMinimum 8+ years of process or plant engineering experience within GMP large molecule biologics manufacturing environmentsProven experience supporting greenfield and/or brownfield biologics manufacturing facility start-upsStrong experience with drug substance manufacturing systems, utilities, automation, and facility integrationDemonstrated expertise in equipment design, commissioning, FAT/SAT execution, and start-up activitiesStrong technical leadership, analytical problem-solving, and cross-functional collaboration skillsDeep understanding of GMP regulations, manufacturing operations, and engineering project executionTop 3 Non-Negotiable SkillsLarge molecule biologics drug substance manufacturing experienceGMP facility start-up, commissioning, and FAT/SAT leadershipProcess equipment design and integrated manufacturing systems expertiseKey ResponsibilitiesLead engineering design, start-up, commissioning, and operational readiness activities for large molecule biologics manufacturing systems and equipmentServe as SME and process systems owner for strategic CAPEX and manufacturing projectsProvide technical leadership for technology transfer initiatives and implementation of new manufacturing technologiesSupport “right first time” execution by integrating process, equipment, utilities, automation, and facility engineering solutionsPartner with external engineering firms, construction teams, and equipment vendors to execute project deliverables, including FAT, SAT, and start-up activitiesCollaborate cross-functionally with Manufacturing, Quality, Engineering, and Technical Operations to align projects with GMP requirements, company standards, and operational goalsEvaluate manufacturing and technology challenges and develop scalable engineering solutions that support business and operational objectivesLead and influence cross-functional teams while managing project risks, technical issues, and execution prioritiesEnsure compliance with GMP regulations, engineering standards, and manufacturing best practicesEducationBachelor’s degree in Chemical Engineering or Mechanical Engineering requiredAdvanced degree (MS, MBA, or PhD) and/or PE certification preferred