Senior Process Engineer
$130,000–$150,000 year
On-sitePittsburgh, Pennsylvania, United States
Job Summary
Lead the development and scale-up of Panther's automated manufacturing process for dissolvable microarray patches, translating pilot-scale operations into robust commercial solutions. Partner with external engineering firms and contract manufacturing organizations to design and implement high-throughput manufacturing lines, ensuring projects remain on schedule, within budget, and aligned with technical requirements. Identify bottlenecks to improve throughput, yield, and reliability while driving continuous process improvements across clinical and commercial campaigns. Support technology transfer activities to external partners, maintaining strict cGMP and medical device compliance. Collaborate cross-functionally with Process Development, Formulation, Quality, and Regulatory teams to enable platform commercialization. Travel regularly to vendor and CMO facilities approximately 25 to 40 percent of the time.
Required Qualifications
- Bachelor's degree or higher in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Process Engineering, Automation Engineering, or a related engineering discipline
- Five or more years of experience in process engineering, manufacturing engineering, or process development within medical devices, biotechnology, pharmaceuticals, or another highly regulated industry
- Proven experience scaling manufacturing processes from pilot to commercial production
- Experience leading complex engineering projects involving external vendors, engineering firms, or contract manufacturers
- Strong understanding of automated manufacturing systems, process optimization, and equipment development
- Experience working within FDA regulated, cGMP, ISO 13485, or similar manufacturing environments
- Strong project management, communication, and cross functional collaboration skills
- Willingness to travel approximately 25 to 40 percent
Desired Qualifications
- Experience building or launching new manufacturing lines or greenfield manufacturing facilities
- Experience leading technology transfer to CMOs or external manufacturing partners
- Knowledge of medical device quality systems, validation, and regulatory requirements
- Experience with automation, robotics, vision systems, or high throughput manufacturing equipment
- Experience supporting clinical manufacturing and commercial product launches
- Experience working in a startup or other fast paced, high growth environment
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