Site Process Engineer

Begell House Inc.; Bend (OR); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

401k

Job summary

Lonza in Bend, Oregon is seeking a Site Process Engineer to provide technical leadership for biologics and pharmaceutical manufacturing processes. You will monitor unit operations, lead investigations, improve yield and quality, and support tech transfer, scale-up, and validation in a cGMP environment.

Collaborating with Manufacturing, QA, MSAT, and Engineering, you will drive data-driven decisions using DOE and statistical analysis, author protocols and regulatory-support documents, and mentor

Qualifications

• 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)

Responsibilities

• 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

Skills

Bioprocess engineering

cGMP operations

Tech transfer

Process validation

DOE

Statistical analysis

Root cause analysis

CAPA

Data analytics

Regulatory knowledge

Cross-functional collaboration

On-floor support

Bioreactors/Filtration/Chromatography

Job description

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)