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.
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
