Single Use Process Scientist Overview We are seeking an experienced Single Use Process Scientistto support new product introductions and process development activities within a GMP biologics/drug product manufacturing environment.
This role is responsible for technical execution, process improvement, and ensuring robust and compliant introduction of new products into manufacturing operations.
Key Responsibilities NPI & Process Engineering Perform gap analyses, facility fit assessments, process safety reviews, and risk analyses for new product introductions.
Assist in developing and optimizing manufacturing processes for new products.
Support process transfers into GMP manufacturing facilities.
Monitor, trend, and analyze manufacturing process data to ensure process control and performance.
Lead or support risk assessments such as PFMEA and EHS risk reviews.
Technical Support & Documentation Provide operational technical support for process-related issue resolution.
Prepare, review, and update specifications for NPI-related materials and consumables.
Develop NPI documentation including transfer plans, protocols, procedures, and batch manufacturing records.
Lead or support product and process investigations, change controls, and CAPA activities.
Cross-Functional Collaboration Work closely with global science, quality, and operations teams to support process development and technology transfer.
Support, supervise, and train manufacturing personnel on NPI processes and single-use technologies.
Compliance Ensure all work complies with GMP, safety, and EHS standards, policies, and procedures.
Essential Requirements Bachelors degree in Engineering, Science, or a related technical discipline.
Experience with Single-Use Technologies (e.g., bioreactors, mixers, tubing assemblies); ability to design single-use assemblies for new projects.
Experience working in a GMP environment with strong documentation and compliance practices.
Hands-on experience with equipment setup, operation, and troubleshooting of single-use and related process systems.
Strong communication skills with the ability to collaborate and train cross-functional teams.
Previous experience in ADC manufacturing.
Experience with process transfer activities in GMP facilities.
Knowledge of cleaning study design.
Experience in upstream processing, UF/DF, mixing, single-use systems, and chromatography.
Ability to work effectively in teams and influence decision-making.
Desired Requirements Masters degree in a relevant technical discipline.
3+ years of experience in pharmaceutical or biologics process engineering, including batch processing, scale-up, and technical transfer.
Experience supporting new product introductions into biologics facilities.
Technical & Professional Skills Minimum 1 year in a similar technical operations or process engineering role.
Minimum 1 year of experience within the pharmaceutical or biotech industry.
Strong technical understanding of unit operations within a fill-finish or biologics manufacturing facility.
For a confidential conversation about the role please apply for the role or contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.