Sr Process Engineer
Katalyst Healthcares and Life Sciences
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.
- pply 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.
- uthor 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.
- 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.
- 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.
Vacancy posted 3 days ago
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