Process Engineer

Process Engineer, Manufacturing Sciences & Technology, Cell Therapy

Location:

AstraZeneca, Rockville, MD

Travel:
Up to 15% domestic and international travel required

Position Summary

We are seeking an experienced Process Engineer to join our Manufacturing Sciences & Technology (MS&T) function as a member of the site-based MS&T team at AstraZeneca's Rockville, MD cell therapy manufacturing facility.

This position focuses on ensuring robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy products.

Key Responsibilities

Site Manufacturing Support

• Process Execution Support:
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)

• Operations Support:
Represent Site MS&T function at site operational tier meetings, providing collaborative inputs that drive site activities

• Data Trending and Analysis:
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.

• Process Performance Monitoring:
Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes.

• Deviation/CAPA Support:
Lead or co-lead technical investigations for deviations and process excursions, perform root cause analysis, develop and implement CAPAs with appropriate data.

• Continuous Improvements:
Identify, justify, and implement continuous improvements by shepherding changes through cross-functional change controls with appropriate risk assessments and comparability.

• Raw Materials:
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

• Automation:
Partner with automation/digital manufacturing teams to implement electronic batch record improvements

• Documentation & GMP Compliance:
Author and revise batch records, SOPs, and technical reports; protocols, summary reports, ensure adherence to cGMP/ATMP requirements and data integrity principles (ALCOA+).

• Training & Knowledge Transfer:
Deliver operator training on critical process steps or process changes; contribute to lessons-learned, playbooks, and best practices across sites.

• Regulatory Contributions:
Draft and review CMC sections (Module
3) response to agency question, support health authority and internal audits/inspections.

Technology Transfer & Process Validation

• Draft and review risk assessments and comparability study design

• Contribute to technology transfer packages (process descriptions, URS inputs, BOMs, risk assessments), implement process changes, coordinate execution of engineering runs and comparability/bridging studies, author technical reports

• Translate process characterization outputs from development into manufacturing controls, and draft sections of PPQ protocols/reports

• Provide on-the-floor technical support during scale-up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off-shift support when required).

Cross-Functional Collaboration

• Position serves as primary interface between site Manufacturing, site Quality, site Supply Chain, and global functions of Process Development and CMC regulatory

• Support lifecycle management for cell therapy processes, including continuous improvement initiatives and post-approval changes

Required Qualifications:

A minimum of a Bachelor's degree with 5+ years of hands-on industry experience is required

Technical Skills

• 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…