AstraZeneca
Cell Therapy
ProcessEngineer
“Process Engineer at AstraZeneca. Skills: Cell Therapy Manufacturing, Process Validation, GMP Environments, Data Analysis. Provide day-to-day technical support. Represent Site MS&T function”
What You'll Achieve.
Ensuring robust, compliant, and cost-effective manufacturing; Driving implementation of CAPAs; Contributing to validation and regulatory deliverables; Supporting technology transfers; Supporting clinical manufacturing; Supporting site readiness; Supporting process validation/PPQ; Supporting commercial manufacture readiness; Supporting product lifecycle management
Industry & Context.
Problem-solving skills; Data analysis; Process performance monitoring; Deviation assessment; Root cause analysis; CAPA implementation; Risk assessments; Comparability
Up to 15% domestic and international travel required, Occasional off-shift support where required, On-call rotation during engineering/PPQ/critical campaigns
What They're Looking For.
Must Have
Bachelor's degree, 5+ years of hands-on industry experience, technical and hands-on expertise in key cell therapy unit operations, common cell therapy processing equipment, Demonstrated experience working in GMP environments, batch record execution or review, deviations, investigations, Proficiency with statistical analysis, univariate analysis, multi-variate analysis, control charts, Demonstrated ability in accurate and thorough technical writing, clear and concise verbal communication, data analysis, problem-solving skills
Nice to Have
PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field, M.S. with 2+ years of hands-on industry experience, Experience with late-stage clinical manufacturing support of cell therapy products, Experience with process validation and commercial readiness of cell therapy products
What You'll Do.
Provide day-to-day technical support
Represent Site MS&T function
Maintain manufacturing data tracking system
Perform trend analyses
Conduct batch record review
Lead technical investigations for deviations
Identify continuous improvements
Support qualification of critical materials
Partner with automation/digital manufacturing teams
Author and revise batch records
Deliver operator training
Draft and review CMC sections
Support technology transfer packages
Implement process changes
Coordinate execution of engineering runs
Translate process characterization outputs
Provide on-the-floor technical support
How You'll Work.
Team & Collaboration
Represent Site MS&T function at site operational tier meetings; Provide collaborative inputs that drive site activities; Align with cross-functional teams; Position serves as primary interface between site Manufacturing, site Quality, site Supply Chain, and global functions; Cross-functional collaboration
Communication Scope
Clear and concise verbal communication; Cross-functional communication; Communication under time-sensitive conditions; Translate complex data into clear decisions
Process & Methodology
Shepherding changes through cross-functional change controls, Coordination of engineering runs and comparability bridging studies
Applying for this Process Engineer role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about AstraZeneca?
Real rants from real employees. Read before you apply.