Process Engineer

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 Raritan, NJ.No Third-Party, No Corp to Corp, No Sponsorship Now, Future or Current Temporary AuthorizationTitle: Process Engineer (MSAT) Location Raritan, NJ Onsite (Mon-Fri, 40 hours)Contract Duration: 12 months, with likely extensionPay Rate: $51.48 per hour (w2)Position OverviewWe are seeking a Senior Material Excellence Engineer, Site MSAT to lead theglobal implementation of dual sourcing strategies for lentiviral materials as partof Project S.U.R.G.E. (Single Use Resiliency & Growth Evolution). This role willhelp strengthen manufacturing reliability, innovation, sustainability, andprocess robustness across global sites and manufacturing operations. Theposition will work closely with cross functional teams, site and global leadership,manufacturing organizations, suppliers, and external partners to successfullyexecute critical material and process initiatives.The ideal candidate brings strong project management capabilities, technicalknowledge of biological manufacturing, and the ability to operate effectively ina complex global matrix environment. Experience with viral manufacturing,lentiviral vectors, cellular therapies, or other advanced therapies is highlydesirable.Key ResponsibilitiesLead process improvement initiatives focused on the dual sourcing ofmaterials used in lentiviral manufacturing to improve reliability, resiliency,process performance, and operational effectiveness.Develop and manage detailed project plans for dual sourcing initiativesunder Project S.U.R.G.E., including timelines, deliverables, milestones,risks, and cross functional dependencies.Lead activities related to vendor and material identification, includingidentifying materials for dual sourcing, developing User RequirementsSpecifications, reviewing and approving vendor drawings, conductingformal comparability assessments, defining material quality attributes,and creating and implementing change controls.Support the development and implementation of standard processes forsupply chain management, logistics, and distribution to improveoperational effectiveness.Partner with production and manufacturing teams to optimize resources,improve manufacturing performance, reduce costs, and strengthenprocess robustness.Drive organizational change through effective project management,stakeholder engagement, and communication strategies.Coordinate team activities, delegate responsibilities, and provide cleardirection to support successful project execution.Monitor and analyze manufacturing performance and identifyopportunities for process improvement, cost reduction, increasedreliability, and operational excellence.Conduct risk assessments and develop mitigation strategies to addresstechnical, operational, and project risks.Create clear visuals, analytics, and project reporting to communicatecritical paths, key handoffs and transitions, milestones, and high levelschedules.Collaboration and CommunicationCollaborate with local and global stakeholders across MSAT,manufacturing, production, supply chain, quality, project teams, andleadership organizations.Represent Site MSAT in internal and external meetings and communicatemanufacturing requirements, technical considerations, project status, andkey insights.Build effective relationships with internal and external partners andfacilitate alignment across a global organization.Required QualificationsBachelor’s degree in Biochemistry, Biotechnology, Chemical Engineering,or a related scientific or engineering discipline.Approximately 5 years of experience in the pharmaceutical orbiotechnology industry.At least 3 years of project management experience.Strong knowledge of biological manufacturing processes, includingupstream and downstream processing.Working knowledge of material specifications, User RequirementsSpecifications, comparability assessments, and change control processes.In depth knowledge of cGMP guidelines and Health Authority regulations,including FDA and EMA requirements.Demonstrated proficiency with Microsoft Project.Strong proficiency with Microsoft PowerPoint and Excel.Excellent written and verbal communication skills.Ability to independently solve complex technical and operationalchallenges and work effectively in a cross functional team environment.Preferred QualificationsExperience with lentiviral vectors, viral manufacturing, cellular therapies,advanced therapies, or related biologics manufacturing.Experience working within a global matrix organization.Professional project management certification such as PMP or CPM.Fluent written and spoken English.