Site Process Engineer
Job in
Bend, Deschutes County, Oregon, 97707, USA
Listed on 2026-09-07
Listing for:
Begell House Inc.
Full Time
position Listed on 2026-09-07
Job specializations:
-
Engineering
Quality Engineering, Process Engineer, Regulatory Compliance Specialist -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Lonza is seeking a Site Process Engineer to provide technical leadership for biologics and pharmaceutical manufacturing processes. In this role, you will monitor and optimize unit operations, lead investigations and root-cause analyses, and drive yield, robustness, and quality improvements in a cGMP environment. You will support tech transfer, scale-up, and validation of clinical and commercial processes, partnering closely with Manufacturing, QA, MSAT, and Engineering.
This role offers exposure to advanced bioprocess technologies, global projects, and a collaborative, science-driven culture focused on patient impact and continuous learning.
- Lead technical oversight of biologics and pharmaceutical manufacturing processes at the site
- Execute process monitoring, data trending, and root-cause investigations for deviations
- Implement process improvements to enhance yield, robustness, and product quality
- Transfer new or optimized processes into GMP manufacturing in collaboration with global teams
- Author and review technical protocols, reports, and regulatory-support documents
- Partner with QA, Manufacturing, MSAT, and Engineering to ensure cGMP and safety compliance
- Support scale-up, validation, and tech transfer activities for clinical and commercial products
- Provide on-floor technical support and training to operations staff
- Use statistical tools and data analytics to drive evidence-based decisions
- Contribute to continuous improvement and innovation initiatives across the site
- Bioprocess engineering (upstream and/or downstream)
- cGMP manufacturing operations
- Process validation and tech transfer
- Statistical analysis and DOE
- Root cause analysis and CAPA
- Process monitoring and data trending
- Bioreactors, filtration, and chromatography systems
- Technical writing for protocols and reports
- Regulatory and quality compliance (FDA/EMA, ICH)
- Cross-functional collaboration and project management
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- 401k
- Six Sigma Green Belt or Black Belt (preferred)
- Lean Manufacturing or Operational Excellence training
- cGMP and FDA/EMA regulatory knowledge
- Certification in Process Engineering or Bioprocessing (e.g., ASQ, ISPE)
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