Staff Engineer, Advanced Operations

What You Will Do

• Lead the development, optimization, and control of upstream and downstream biologics manufacturing processes across internal and supplier operations.
• Conduct process characterization, variability, hold-time, and worst-case condition studies to establish process robustness and define in-process control strategies.
• Evaluate, select, and qualify manufacturing equipment and components based on technical specifications, reliability requirements, and applicable regulations; support equipment installation and validation activities.
• Generate and review technical documentation including PFMEAs, Control Plans, SOPs, PPAPs, validation protocols, capability studies, MSA studies, and inspection documentation to support product launches.
• Mentor engineers, provide technical guidance across multiple product portfolios, and deliver technical updates and recommendations to stakeholders and leadership.
• What You Will Need
• Required:
• Bachelor’s degree in Mechanical Engineering or a related engineering discipline.
• Minimum 7 years of engineering experience in manufacturing, process development, product development, or a related field.
• Minimum 7 years of experience supporting regulated manufacturing environments.
• Experience developing and validating manufacturing processes, including statistical analysis and verification/validation methodologies.
• Experience interpreting engineering drawings, specifications, and geometric dimensioning and tolerancing (GD&T).
• Experience with Design for Manufacturing (DFM), process capability studies, and measurement system analysis (MSA).
• Preferred:
• Experience supporting biologics manufacturing or biologics process development.
• Experience in FDA-regulated or ISO 13485-regulated industries and supporting complex global supply chains.
• United States of America Pay Ranges:
• USN: $89,300 - $148,800 USD Annual
• US20: $107,200 - $178,600 USD Annual
• View the U.S. work location and transparency guide to find the pay range for your location.