Process Engineer

BioXtek LLC

Pompano Beach, FL

Pay: $85,000-$105,000/yr

Shift: Full time

**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: $85,000.00 - $105,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Retirement plan

Work Location: In person