Operations Engineer - Peptide API

Operations Engineer

We are looking for 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. The ideal candidate is technically strong, highly adaptable, and eager to take ownership in a fast-paced, developing environment operating within applicable regulatory frameworks.

You will:

• 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.
• Assist 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 R&D into commercial manufacturing.
• Identify opportunities to optimize manufacturing processes, reduce waste, and improve operational performance.
• Author and maintain SOPs, batch records, technical reports, and other GMP documentation.
• Support deviation investigations, 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 QA/QC to ensure product quality, regulatory compliance, and inspection readiness.
• Operate within applicable, evolving regulatory frameworks
• Support internal and external audits while adhering to all safety, environmental, and quality standards.
• Partner cross-functionally with R&D, Engineering, Quality, and Supply Chain to ensure seamless manufacturing operations and successful introduction of new materials and processes.

You have:

• Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, or a related scientific discipline.
• 2+ years of experience in pharmaceutical, biotechnology, or chemical manufacturing.
• Experience supporting peptide synthesis, API manufacturing, or similarly complex chemical manufacturing processes strongly 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.

Our benefits (there are more but here are some highlights):

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats