Senior Manufacturing Process Engineer

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.