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Sr Process Engineer
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-10-05
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-10-05
Job specializations:
-
Manufacturing / Production
Quality Engineering, Lean Manufacturing / Six Sigma, Manufacturing Engineer, Validation Engineer
Job Description & How to Apply Below
- Serve as a technical process owner for peptide manufacturing operations, including SPPS, purification, and lyophilization.
- Support manufacturing teams during batch execution and provide real-time technical troubleshooting on the floor.
- Monitor critical process parameters and key performance indicators across peptide manufacturing processes.
- Collect, analyze, and trend manufacturing data to identify process variability, yield losses, bottlenecks, and improvement opportunities.
- Develop and maintain manufacturing dashboards tracking yield, cycle time, solvent usage, throughput, batch success rate, and right-first-time metrics.
- Evaluate coupling efficiency, resin performance, deprotection efficiency, impurity formation trends, and other process indicators related to SPPS performance.
- Identify and implement improvements to reaction conditions, cycle parameters, manufacturing practices, and process controls.
- Lead initiatives to improve product yield, throughput, cycle time, overall equipment effectiveness, and process robustness.
- Apply Lean Manufacturing, Six Sigma, statistical analysis, and structured root cause analysis tools to reduce waste and process variation.
- Lead or support investigations related to process excursions, atypical results, yield losses, manufacturing deviations, and equipment/process issues.
- Use tools such as Fishbone Analysis, 5 Why Analysis, FMEA, and Statistical Process Control to identify root cause and drive corrective actions.
- Author and revise SOPs, Master Batch Records, process descriptions, manufacturing instructions, technical reports, and process performance summaries.
- Support deviation investigations, CAPAs, change controls, risk assessments, process validation, and continued process verification activities.
- Ensure technical documentation is accurate, complete, and compliant with cGMP requirements.
- Partner cross-functionally with Operations, Engineering, Quality, Supply Chain, and site leadership to improve manufacturing performance.
- Support implementation of new equipment, technologies, and manufacturing systems.
- Participate in production planning, operational excellence reviews, and process improvement meetings.
- Provide technical mentoring and training to manufacturing personnel on process understanding and best practices.
- Serve as a technical process owner for peptide manufacturing operations, including SPPS, purification, and lyophilization.
- Support manufacturing teams during batch execution and provide real-time technical troubleshooting on the floor.
- Monitor critical process parameters and key performance indicators across peptide manufacturing processes.
- Collect, analyze, and trend manufacturing data to identify process variability, yield losses, bottlenecks, and improvement opportunities.
- Develop and maintain manufacturing dashboards tracking yield, cycle time, solvent usage, throughput, batch success rate, and right-first-time metrics.
- Evaluate coupling efficiency, resin performance, deprotection efficiency, impurity formation trends, and other process indicators related to SPPS performance.
- Identify and implement improvements to reaction conditions, cycle parameters, manufacturing practices, and process controls.
- Lead initiatives to improve product yield, throughput, cycle time, overall equipment effectiveness, and process robustness.
- Apply Lean Manufacturing, Six Sigma, statistical analysis, and structured root cause analysis tools to reduce waste and process variation.
- Lead or support investigations related to process excursions, atypical results, yield losses, manufacturing deviations, and equipment/process issues.
- Use tools such as Fishbone Analysis, 5 Why Analysis, FMEA, and Statistical Process Control to identify root cause and drive corrective actions.
- Author and revise SOPs, Master Batch Records, process descriptions, manufacturing instructions, technical reports, and process performance summaries.
- Support deviation investigations, CAPAs, change controls, risk assessments, process validation, and continued process verification activities.
- Ensure technical documentation is accurate, complete, and compliant with cGMP requirements.
- Partner cross-functionally with Operations, Engineering, Quality, Supply Chain, and site leadership to improve manufacturing performance.
- Support implementation of new equipment, technologies, and manufacturing systems.
- Participate in production planning, operational excellence reviews, and process improvement meetings.
- Provide technical mentoring and…
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