Operations Engineer - Peptide API

About the role

We are seeking a hands-on Operations Engineer to support and scale manufacturing operations in a peptide API facility. This role will work closely with the Operations Manager to execute daily production, troubleshoot processes, and help build robust, GMP-compliant systems.

Responsibilities

• Support daily peptide API manufacturing operations, including solid-phase peptide synthesis (SPPS), purification (HPLC), and lyophilization.
• Troubleshoot manufacturing and process issues in real time to minimize downtime and maximize batch success.
• Aid in the execution of production batches, including equipment setup, process monitoring, and batch documentation.
• Analyze manufacturing performance, including yield, cycle time, and deviations, and implement process improvements to enhance efficiency and robustness.
• Support process scale-up activities and technology transfers from Research and Development (R&D) into commercial manufacturing.
• Identify opportunities to optimize manufacturing processes, reduce waste, and improve operational performance.
• Author and maintain Standard Operating Procedures (SOPs), batch records, technical reports, and other GMP documentation.
• Support deviation investigations, Corrective and Preventative Action Plans (CAPAs), change controls, and continuous improvement initiatives.
• Ensure accurate, timely, and compliant documentation in accordance with cGMP requirements.
• Assist with equipment commissioning, qualification (IQ/OQ/PQ), calibration, preventive maintenance, and maintenance coordination.
• Partner with Engineering to troubleshoot equipment issues and support equipment upgrades and reliability initiatives.
• Collaborate closely with Quality Assurance (QA)/Quality Control (QC) to ensure product quality, regulatory compliance, and inspection readiness.
• Partner cross-functionally with Research and Development (R&D), Engineering, Quality, and Supply Chain to ensure seamless manufacturing operations and successful introduction of new materials and processes.

Requirements

• Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, or a related scientific discipline.
• 2+ years of experience in pharmaceutical, biotechnology, or chemical manufacturing.
• Prior experience supporting peptide synthesis, API manufacturing, or similarly complex chemical manufacturing processes is preferred.
• Prior experience working in a startup or other fast-paced, high-growth manufacturing environment is a plus.
• Hands-on experience troubleshooting manufacturing processes and equipment in a production environment.
• Strong understanding of chemical manufacturing principles with the ability and desire to learn peptide manufacturing processes.
• Experience executing process improvements and translating technical plans into operational results.
• Working knowledge of cGMP principles, including documentation, compliance, and quality systems.
• Strong attention to detail with a commitment to maintaining accurate GMP documentation and high-quality standards.
• Ability to adapt quickly to changing priorities and thrive in a dynamic, evolving environment.
• Excellent collaboration and communication skills, with the ability to work effectively across Engineering, Manufacturing, Quality, R&D, and Supply Chain teams.
• Willingness to work flexible hours as needed to support manufacturing operations and production schedules.