Senior Manufacturing Process Engineer

Spyglass Pharma • Aliso Viejo, CA

5d • $130,000 - $150,000

About The Position

We’re seeking a Senior Manufacturing Process Engineer, Technical Operations to join our team at SpyGlass Pharma. This role supports manufacturing scale-up, process improvements, technology transfer, and coordination with external manufacturing partners for pharmaceutical and drug-device combination products. Working closely with R&D Engineering, Quality, Regulatory, and Supply Chain, this position helps ensure manufacturing processes are reliable, scalable, and compliant while supporting key clinical and commercial milestones. The ideal candidate is a hands-on problem solver who takes ownership of projects and thrives in a fast-paced pharmaceutical or medical device development environment.

Requirements

• Bachelor’s degree in Engineering or related technical field required; advanced degree preferred.
• 3-5+ years of experience in pharmaceutical, medical device, or combination product manufacturing, with exposure to scale-up, tech transfer, validation, and CMO oversight.
• Experience working with Contract Manufacturing Organizations (CMOs), including technical transfers and performance oversight.
• understanding of cGMP, FDA regulations, and applicable quality standards.
• Experience in ISO 5/7/8 environments and controlled manufacturing processes preferred.
• Exposure to automation, inspection systems, and fixture design is preferred.
• Demonstrated ability to contribute to cross-functional initiatives and coordinate with Engineering, Quality, Regulatory, and Supply Chain.
• Structured problem-solving skills, including risk assessment and data-driven decision-making.
• Experience with ophthalmic products, drug–device combination products, or implantable systems is highly desirable.

Nice To Haves

• Experience with ophthalmic products, drug–device combination products, or implantable systems is highly desirable.

Responsibilities

• Serve as a key technical contributor in efforts to scale, stabilize, and optimize manufacturing processes in ISO 5/7/8 environments.
• Collaborate on process validation strategy and execution with Quality and CMOs.
• Ensure manufacturing processes are efficient, compliant, and inspection-ready.
• Maintain disciplined documentation practices to support regulatory submissions, audits, and lifecycle management.
• Provide structured project updates, risk assessments, and mitigation plans to leadership.
• Serve as technical liaison between SpyGlass and CMOs.
• Serve as a key technical contributor in leading technology transfers from R&D to commercial manufacturing in partnership with department heads, ensuring smooth execution.
• Support validation strategies, change controls, and technical documentation alignment.
• Monitor performance and identify potential quality, cost, or supply risks.
• Foster accountability and collaboration with external manufacturing partners.
• Participate in the development and implementation of scalable inspection platforms and custom fixtures.
• Support improvements in inspection robustness, throughput, and repeatability.
• Ensure inspection systems meet regulatory and operational requirements.
• Ensure alignment with cGMP and applicable regulatory requirements.
• Support audit readiness and regulatory inspections.
• Assist in root cause investigations and corrective actions.
• Contribute to continuous improvement initiatives to enhance reliability and reduce operational complexity.

Benefits

• We are offering a range of $130,000 - $150,000, based on experience and qualifications, along with an Annual Bonus opportunity.
• Share in our success with stock options, giving you a stake in the company’s future.
• Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options.
• Generous paid time off, including holidays, vacation days, and personal leave.
• SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.
• SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [email protected] and let us know the nature of your request and your contact information.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level