Operations Engineer - Peptide API

About the Role:

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.

• 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.

• 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.

• 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).
• 401(k) benefits with employer matching contribution.
• Offsite team retreats.

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