Sr Process Engineer

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.