Process Engineer

Responsibilities

• Provide day-to-day technical support for cell therapy manufacturing, including on-the-floor support for critical campaigns (including occasional off-shift support where required)
• Represent Site MS&T function at site operational tier meetings, providing collaborative inputs that drive site activities
• Maintain manufacturing data tracking system and control charts, perform trend analyses, identify signals, and drive timely signal-to-action with clear documentation and cross-functional alignment
• Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes
• Lead or co-lead technical investigations for deviations and process excursions, perform root cause analysis, develop and implement CAPAs with appropriate data
• Identify, justify, and implement continuous improvements by shepherding changes through cross-functional change controls with appropriate risk assessments and comparability
• Support qualification of critical materials (e.g., cytokines, viral vector, single-use assemblies) and assess impact of raw material changes, and contribute to second-source strategies
• Partner with automation/digital manufacturing teams to implement electronic batch record improvements
• Author and revise batch records, SOPs, and technical reports; protocols, summary reports, ensure adherence to cGMP/ATMP requirements and data integrity principles (ALCOA+)
• Deliver operator training on critical process steps or process changes; contribute to lessons-learned, playbooks, and best practices across sites
• Draft and review CMC sections (Module 3) response to agency questions, support health authority and internal audits/inspections
• Translate process characterization outputs from development into manufacturing controls, and draft sections of PPQ protocols/reports
• On-the-floor technical support during scale-up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off-shift support when required)

Qualifications

• A minimum of a Bachelor's degree with 5+ years of hands-on industry experience is required
• Strong technical and hands-on expertise in key cell therapy unit operations and common cell therapy processing equipment
• Demonstrated experience working in GMP environments, including batch record execution or review, deviations, and investigations
• Proficiency with statistical analysis (including univariate, multi-variate analysis, control charts)
• Demonstrated ability in accurate and thorough technical writing, paired with clear and concise verbal communication
• Strong data analysis, and problem-solving skills
• Excellent cross-functional communication and collaboration
• Ability to translate complex data into clear decisions and regulatory-ready narratives
• Excellent problem solving, cross-functional leadership, and communication under time-sensitive conditions