Sr Process Engineer

Katalyst Healthcares & Life Sciences; San Francisco (CA); Vor Ort; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

Creative Solutions Services, LLC is seeking a technical process owner for peptide manufacturing, including SPPS, purification, and lyophilization. You will support manufacturing teams during batch execution and provide real-time technical troubleshooting on the floor.

The role focuses on monitoring critical process parameters and KPIs, collecting and analyzing data to identify variability and bottlenecks, and developing dashboards for yield, cycle time, solvent usage, and throughput.

Qualifikationen

• Bachelor's degree in a relevant field and 3–7 years in pharma/peptide manufacturing.
• Hands-on GMP manufacturing and process validation experience.
• Solid-Phase Peptide Synthesis experience.
• Ability to analyze process data and drive improvements.
• Experience authoring GMP documentation (SOPs, batch records, CAPAs, change controls).

Aufgaben

• Serve as technical process owner for SPPS, purification, and lyophilization.
• Support batch execution with real-time troubleshooting on the floor.
• Monitor KPIs and collect data to identify variability and bottlenecks.
• Develop dashboards tracking yield, cycle time, solvent usage, and throughput.
• Lead or support deviation investigations and CAPAs.
• Author and revise SOPs, MBRs, and process docs.

Kenntnisse

Technical troubleshooting

Root cause analysis

Process understanding

Communication

Cross-functional collaboration

Data analysis

Ausbildung

Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology

Tools

Minitab

Power BI

Excel (advanced analytics)

Jobbeschreibung

Roles and Responsibilities:

• 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.

Education and Experience:

• Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or a related field.
• 3–7 years of experience in pharmaceutical, biotechnology, peptide manufacturing, API manufacturing, or related chemical processing environments.
• Hands-on experience supporting GMP manufacturing operations, investigations, and process validation activities.
• Direct experience with Solid-Phase Peptide Synthesis.
• Experience analyzing manufacturing process data and implementing process improvements.
• Strong technical troubleshooting skills with the ability to identify root cause and implement sustainable corrective actions.
• Experience authoring or revising GMP documentation, including SOPs, batch records, technical reports, deviation investigations, CAPAs, change controls, or risk assessments.
• Strong cross-functional collaboration skills and the ability to work closely with Manufacturing, Quality, Engineering, and Supply Chain teams.
• Clear communication skills with the ability to translate technical process observations into actionable recommendations.

Nice to Have:

• Master's degree or Ph.D. in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or a related field.
• Experience in commercial-scale peptide manufacturing.
• Experience with process monitoring, Statistical Process Control, and process capability assessments.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience using statistical software and data analysis tools such as Minitab, Power BI, Excel advanced analytics, or similar tools.
• Experience in a startup or rapidly growing manufacturing organization.