Single Use Process Scientist

Single Use Process Scientist

Overview We are seeking an experienced Single Use Process Scientist to 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

• Bachelor’s 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

• Master’s 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 oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.