Process Engineer 2/Senior

Responsibilities

Process Engineering & Manufacturing Support

• Provide advanced process engineering support for GMP manufacturing operations including bioconjugation, chromatography, filtration, formulation, and single-use processing systems.
• Provide on-floor technical leadership during manufacturing campaigns, including complex troubleshooting, technical decision support, and issue resolution.
• Partner with Manufacturing and MSAT teams to improve process robustness, throughput, yield, scalability, and execution efficiency.
• Lead technical investigations related to process deviations, operational issues, and adverse process performance trends, including root cause analysis and corrective action development.
• Develop and implement process improvements and engineering solutions that enhance operational reliability and reduce recurring manufacturing risk.

Technology Transfer & Scale-Up

• Lead or serve as the Process Engineering technical lead for technology transfer activities from Process Development into GMP Manufacturing.
• Lead process scale-up assessments, equipment fit evaluations, engineering studies, and manufacturing readiness planning.
• Review and provide technical approval or input for manufacturing records, protocols, technical documents, and process instructions to ensure readiness and technical accuracy.
• Lead or provide technical oversight for process validation, PPQ activities, engineering runs, and process characterization studies.

Technical Leadership & Team Contribution

• Serve as a senior technical resource and mentor to Process Engineers and manufacturing personnel.
• Coach less experienced engineers in troubleshooting, technical writing, investigation methodology, and GMP engineering practices.
• Promote accountability, collaboration, GMP compliance, technical rigor, and continuous improvement across engineering activities.
• Independently prioritize complex engineering work and support the Senior Manager in coordinating technical activities aligned with manufacturing schedules and site objectives.

Quality & Compliance

• Ensure assigned engineering activities are executed in compliance with cGMP regulations, internal procedures, and Abzena quality standards.
• Lead or provide senior technical support for deviations, CAPAs, investigations, change controls, and risk assessments related to process engineering.
• Participate in regulatory inspections and client audits as a technical SME and support preparation of technical responses.
• Drive improvements that reduce repeat deviations, strengthen process consistency, and improve technical control of manufacturing processes.

Operational Excellence

• Analyze process performance metrics, equipment utilization, manufacturing trends, and process capability to identify improvement opportunities.
• Lead Lean and continuous improvement initiatives focused on process efficiency, waste reduction, throughput, and manufacturing effectiveness.
• Develop and implement standardized engineering practices, technical tools, and operational improvements across manufacturing operations.
• Collaborate with Operations leadership to improve schedule adherence, campaign execution reliability, and technical readiness.

Cross-Functional Collaboration

• Partner closely with Manufacturing, MSAT, Quality, Supply Chain, Facilities & Engineering, and Program Management teams.
• Support and, when appropriate, lead client-facing technical discussions related to manufacturing execution, investigations, process performance, and improvement plans.
• Provide technical leadership in campaign planning, operational readiness reviews, and production support activities.
• Identify and escalate significant technical risks, operational constraints, and process concerns to the Senior Manager, Process Engineering with recommended actions.

Qualifications

• Minimum 6+ years of experience within biopharmaceutical, biologics, bioconjugation, ADC, or CDMO manufacturing environments.
• Demonstrated experience independently supporting GMP manufacturing operations and leading complex process engineering activities.
• Strong experience with technology transfer, process scale-up, process troubleshooting, data analysis, and process optimization.
• Experience leading process validation support, engineering studies, manufacturing investigations, and change implementation.
• Experience serving as a technical SME during regulatory inspections or client audits preferred.

Preferred Qualifications

• Experience within bioconjugation, ADC, oligonucleotide, or complex biologics manufacturing environments.
• CDMO experience supporting external clients.
• Experience supporting startup operations or facility expansions.
• Lean Six Sigma or continuous improvement experience preferred.