Senior Manufacturing Process Engineer

Job Description

Job Description

Senior Operations Engineer / Senior Manufacturing Process Engineer

Alachua, FL · $115,000 - $130,000 + up to $10,000 bonus

My client is a global leader in regenerative medicine and a cutting-edge CDMO with manufacturing facilities across four continents. As a Senior Operations Engineer, you'll lead the validation, process development, and cross-functional projects that bring life-changing biomaterial products to patients worldwide.

No C2C or third-party firms. Unable to sponsor employment visas now or in the future.

Why you should apply

• Lead high-impact regenerative medicine manufacturing projects with real patient outcomes
• Join a PE-backed CDMO actively scaling through acquisitions, growth is built in
• Real leadership scope, from project management to potential oversight of other engineers and technicians
• Salary $115,000 - $130,000 annually, plus up to $10,000 annual bonus
• Cross-functional exposure across engineering, quality, and operations at a global scale

What you'll be doing

• Validating equipment and control systems, then writing the protocols and summary reports that document results
• Leading process development and continuous improvement for new and existing products
• Supporting and leading non-conformance investigations and CAPA closure
• Providing project management leadership across multiple initiatives, from core team meetings to reporting
• Leading capital equipment projects for new and upgraded manufacturing lines
• Leading cross-functional teams on lean manufacturing, cost savings, and new product launches

About you

• Be able to do the job as described.
• Engineering degree, or equivalent hands-on experience, building and implementing processes and equipment
• Experience with Class III medical devices in an ISO 13485 regulated environment
• Proven ability to lead cross-functional projects, with potential to mentor or oversee other engineers and technicians
• Strong technical writer who can translate complex validation work into clear documentation

Additional Information

• Applicants must be authorized to work in the United States without the need for current or future employer-sponsored work authorization.
• At this time, we are unable to sponsor employment visas for this role, now or in the future.