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.
