Process Engineer

Process Engineer BioXtek LLC Pompano Beach, FL Job Details Full-time $70,000 - $90,000 a year 3 hours ago Benefits Dental insurance 401(k) Retirement plan Qualifications ISO standards Bachelor of Science Regulatory compliance Laboratory experience Research Microsoft Office Bachelor's degree in engineering Continuous improvement Experimental design Research data analysis Root cause analysis Electrical Engineering FDA regulations Full Job Description About BioXtek BioXtek is a pioneering regenerative therapeutics company dedicated to processing placental tissue-derived biologics and exosomes. We're at the forefront of the regenerative medicine revolution, developing innovative solutions that are transforming healthcare and improving patient outcomes. Position Overview We're seeking a talented Process Engineer to join our Operations team. In this role, you'll develop and optimize industrial processes for our cutting-edge regenerative biologic products. You'll be responsible for designing equipment, understanding critical process interfaces and reactions, installing control systems, and managing process startup, operation, and upgrades. This is a project-oriented position where you'll work on multiple initiatives at various stages simultaneously. Key Responsibilities Create and update manufacturing drawings, process records, SOPs, and detailed technical documentation Design, install, and commission new production units while troubleshooting existing processes and equipment Develop and execute product and process validation protocols Conduct process development experiments and support scale-up from laboratory to commercial operations Assess biologic assay, storage, and testing equipment for adequacy and functionality Analyze data to determine research requirements and prepare technical reports, flow diagrams, and charts Manage project cost and time constraints while ensuring regulatory compliance Collaborate with scientists, engineers, and manufacturing teams to optimize efficiency, output, and safety Support the conversion of small-scale processes into commercially viable large-scale operations

Required Qualifications Education:

Bachelor's of Science Degree in Engineering (Mechanical, Electrical, Industrial, Manufacturing, or related technical field)

Experience:

5+ years of experience with new process development in a highly regulated environment (biologics, medical devices, pharmaceuticals, or food) Strong statistical background for data analysis, root cause analysis, and Design of Experiments (DOE) Experience with Lean or Six Sigma tools for continuous improvement

Certifications:

Six Sigma Green Belt (or higher) training/certification preferred

Knowledge & Skills:

Knowledge of FDA, AATB, ISO, and other applicable regulatory guidance Understanding of Quality, Regulatory, and Operations functions Proficient in MS Office Excellent written and verbal communication skills Strong strategic planning and problem-solving abilities Outstanding organizational and interpersonal skills Physical Requirements Ability to stand for up to 8 hours per working day Fine finger hand dexterity and good hand-eye coordination required Spatial visualization skills essential Ability to occasionally lift office products and supplies up to 40 pounds May require sitting on laboratory stool for 3-4 hours at a time Work Environment This position operates in both a professional office environment and on the manufacturing floor, utilizing standard office equipment as well as specialized laboratory and manufacturing equipment including ULT freezers, medical-grade refrigerators, lyophilizers, autoclaves, and freezer mills. Why Join BioXtek? Be part of the regenerative medicine revolution Work with cutting-edge biotechnology and innovative therapeutic solutions Collaborate with a team of dedicated scientists and engineers Opportunity to make a meaningful impact on patient health and outcomes Professional growth in a dynamic, highly regulated biotech environment To Apply Please submit your resume and cover letter detailing your relevant process engineering experience in regulated environments.

Pay:

$70,000.00 - $90,000.00 per year

Benefits:

401(k) Dental insurance Retirement plan

Work Location:

In person