Job Title:Single-Use Process ScientistDepartment:Technical OperationsReports To:NPI Technical ManagerContract:12-month contract, day shift, 100% onsiteOverview:The Single-Use Process Scientist will join the Technical Operations team (approx. 10 people, split between process/equipment and product/NPI support) to support the installation and operational readiness of a new fill-finish line. The role acts as a subject matter expert (SME) on single-use technologies and new processes, collaborating closely with cross-functional groups including Quality, Operations, Engineering, and Sterility Assurance. The successful candidate will contribute to process development, technology transfer, documentation creation, troubleshooting, and readiness activities for new product introductions (NPI).ResponsibilitiesPerform gap analyses, facility fit studies, process safety assessments, and risk analyses for new product introductions.Monitor, interpret, and trend process data during manufacturing campaigns.Support and/or lead the development and optimization of manufacturing processes for new products.Provide technical support and troubleshooting for process-related issues.Prepare and update specifications for NPI-related materials, consumables, and single-use assemblies.Lead or assist in risk assessments (e.g., PFMEA, EHS).Develop and maintain NPI documentation, including transfer plans, protocols, procedures, and manufacturing batch records.Liaise with cross-functional teams to ensure operational readiness for new equipment and processes.Assist and/or lead product and process investigations, change controls, and improvement initiatives.Support, supervise, and train operations personnel in NPI and single-use system processes.Ensure adherence to all relevant EHS&E standards, policies, and procedures.Serve as SME for single-use technologies during installation, commissioning, and qualification of the new fill-finish line.Contribute to cleaning study design and execution where required.Essential RequirementsBachelor's degree (or equivalent) in a relevant engineering, science, or technical discipline.Minimum of 2 years experience in a similar role.Minimum of 2 years experience within pharmaceutical or biopharmaceutical industries.Strong technical knowledge of unit operations within a fill-finish facility.Desired RequirementsMaster's degree in a relevant technical discipline.3+ years' experience in pharmaceutical or biologics process engineering, including batch processing, technical transfers, scale-up, or new product introduction.Experience with biologics manufacturing (fill-finish or drug substance). API experience may be considered but is not preferred.Experience supporting new product introductions in biologics facilities.Six Sigma certification desirable but not essential.Technical & Business SkillsSingle-Use Technologies Expertise:Experience with single-use bioreactors, mixers, tubing assemblies, connectors, and design of single-use assemblies for new projects.GMP Compliance & Documentation:Strong understanding of GMP, batch records, deviation management, and regulatory expectations.Equipment Setup & Troubleshooting:Hands-on experience with installation, operation, and troubleshooting of single-use systems and process equipment.Communication & Teamwork:Ability to collaborate cross-functionally, communicate effectively, and train/mentor others.Preferred Experience:Antibody–drug conjugate (ADC) manufacturingProcess transfer within GMP facilitiesCleaning study designUpstream processing, UF/DF, mixing, chromatography, and broader single-use operationsInfluence & Decision-Making:Demonstrated ability to work within teams and contribute to decision-making processes.