The Senior Process Engineer provides advanced process engineering support and technical leadership for GMP manufacturing operations at the Bristol, PA site. Responsibilities include technical leadership of manufacturing campaigns, complex process troubleshooting, technology transfer, process optimization, scale-up, engineering studies, and operational readiness activities.
Reporting to the Director, Process Engineering, the Senior Process Engineer works cross-functionally with Manufacturing, MSAT, Quality, Facilities & Engineering, Supply Chain, and Program Management to support safe, compliant, reliable, and effective manufacturing operations. The role serves as a senior technical subject matter expert, independently leads complex engineering activities, provides technical guidance and mentorship to less experienced engineers, and drives improvements in process performance and reliability within bioconjugation and biologics manufacturing operations.
Responsibilities
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Process Engineering & Manufacturing Support
Technology Transfer & Scale-Up
Technical Leadership & Team Contribution
Quality & Compliance
Operational Excellence
Cross-Functional Collaboration
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.
- 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.
Preferred Qualifications
FLSA: Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.