Process Engineer at Abzena Inc. – Bristol, Pennsylvania

The Process Engineer supports the design, optimization, and execution of antibodydrug conjugate (ADC) and biologics manufacturing processes. This role is responsible for implementing closedprocessing improvements, ensuring GMP equipment readiness, designing singleuse consumables, resolving technical issues, and developing mass balance and process monitoring tools. The Process Engineer also supports ADCspecific needs, including handling highly potent APIs (HPAPIs), supporting conjugation process characterization, performing scaleup/scaledown assessments, collaborating on technology transfers, and developing workflows for buffers and HPAPI waste.

This role requires strong technical judgment, crossfunctional collaboration, and the ability to perform handson support in a fastpaced GMP manufacturing environment.

• Process Development, Characterization & ScaleUp

  • Lead closedprocessing improvement initiatives across conjugation and purification operations.

  • Support characterization studies, including DOEs to assess process robustness and critical process parameters.

  • Perform scaleup and scaledown assessments for conjugation, purification, and formulation steps.

  • Support engineering runs and process modeling activities.

• ADC & HighPotency Processing

  • Support handling strategies for highpotency APIs and payloads, including containment, zoning, and workflow design.

  • Perform risk assessments (FMEA, HAZOP, potentcompound assessments) and implement CAPAs tied to deviations.

  • Partner with EHS and Operations to ensure closedprocessing and operator protection requirements are met.

  • Support evaluation and implementation of equipment and consumables compatible with HPAPI containment levels.

• Consumable, Raw Material & SingleUse System Design

  • Lead design and optimization of tubing sets, flowpaths, and singleuse assemblies for ADC processes.

  • Support raw material and consumable qualification activities, including evaluation of linkers, solvents, and process reagents.

  • Partner with vendors on customization, testing, and introduction of new technologies.

• Process Monitoring, Data Trending & Mass Balance

  • Develop and maintain mass balance tools for ADC and biologics workflows.

  • Build process monitoring dashboards to track yields, CPPs, DAR (DrugtoAntibody Ratio), impurities, and cycle times.

  • Support Continued Process Verification (CPV) activities.

• Technology Transfer

  • Participate in internal and external tech transfers by supporting gap analyses, equipment fit studies, and material/component mapping.

  • Support firstinplant demonstrations, engineering batches, and troubleshooting during transfer.

• GMP Equipment & Facility Readiness

  • Support equipment readiness through URS review, FAT/SAT execution, qualification support, and lifecycle documentation.

  • Troubleshoot equipment and process issues in partnership with Facilities, MSAT, QA, and Manufacturing.

• Validation & Compliance

  • Support process validation activities, including protocol writing, execution assistance, data analysis, and reporting.

  • Ensure compliance with GMP standards, site procedures, and regulatory expectations.

  • Support both internal and external audits. Address audit actions with a timely action driving resolution and compliance.

• Buffer & Waste Workflow Optimization

  • Design and improve workflows for buffer preparation, hold strategies, and inprocess sampling.

  • Support capacity modeling, facility fit assessments, and workflow optimization.

• Documentation & Technical Support

  • Author or revise SOPs, P&IDs, equipment matrices, and process flow diagrams.

  • Provide onthefloor support during manufacturing operations, including troubleshooting deviations and supporting investigations.

  • Prepare technical presentations and reports for internal teams and external partners.

• Bachelor’s degree in Chemical, Biomedical Engineering or related scientific field.

• 3–5 years of experience in biopharmaceutical and/or biologics.

• Strong understanding of GMP operations and equipment used in biologics/ADC processing.

• Experience with mass balance modeling, process characterization, or engineering analyses.

• Ability to write technical documentation including SOPs, deviations/CAPAs, protocols, and reports.

• Demonstrated ability to support investigations, troubleshooting, and rootcause analysis.

• Strong communication skills and ability to work effectively across teams.

• Project management experience, including scheduling, risk evaluation, and coordination.

• 2+ years of experience in ADC manufacturing, MSAT or process engineering