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Cell Therapy Process Development Engineer Jobs (NOW HIRING)

Actalent

Process Development Engineer

Maple Grove, MN · On-site

$53 - $65/hr

Process Development Engineer We are seeking a Process Development Engineer to support the development, validation, and transfer of manufacturing processes for valve-based medical devices and ...

Eastman

Process Development Engineer

Fieldale, VA · On-site

Description This posting is for a Process Development Engineer in the Performance Films Technology Organization at Eastman Chemical Company located in Martinsville, VA. Individual will be primarily ...

Eastman

Process Development Engineer

Fieldale, VA · On-site

Description This posting is for a Process Development Engineer in the Performance Films Technology Organization at Eastman Chemical Company located in Martinsville, VA. Individual will be primarily ...

BrainChild Bio

Process Engineer

Seattle, WA · On-site

$105K - $115K/yr

Qualifications: 4-5+ years in life sciences supporting process development or manufacturing process improvement and support activities preferably in cell therapy Proficiency with life science data ...

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Cell Therapy Process Development Engineer information

See salary details

$45.5K

$101.6K

$152.5K

How much do cell therapy process development engineer jobs pay per year?

As of Sep 14, 2026, the average yearly pay for cell therapy process development engineer in the United States is $101,612.00, according to ZipRecruiter salary data. Most workers in this role earn between $80,500.00 and $119,000.00 per year, depending on experience, location, and employer.

What does a cell therapy process development engineer do?

A Cell Therapy Process Development Engineer is responsible for designing, optimizing, and scaling up processes used to manufacture cell-based therapies for clinical and commercial use. They work closely with research scientists, manufacturing teams, and quality assurance to ensure that cell therapy products are produced safely, efficiently, and consistently. Their work often includes developing protocols, troubleshooting production issues, implementing new technologies, and ensuring regulatory compliance in a highly controlled environment.

What are the key skills and qualifications needed to thrive as a cell therapy process development engineer?

To thrive as a Cell Therapy Process Development Engineer, you need a strong background in biomedical engineering, cell biology, or a related field, often with advanced degrees and experience in cell culture techniques. Familiarity with bioprocessing equipment, automation systems, and regulatory standards such as GMP is typically required, along with knowledge of analytical tools for process characterization. Strong problem-solving skills, attention to detail, and effective collaboration are critical soft skills in this role. These competencies are essential to ensure robust, scalable, and compliant cell therapy manufacturing processes that meet quality and safety standards.

What are some common challenges faced by cell therapy process development engineers when scaling up processes from the lab to clinical or commercial manufacturing?

Cell Therapy Process Development Engineers often encounter challenges when translating small-scale laboratory protocols to large-scale manufacturing, such as maintaining cell viability and product consistency. Ensuring reproducibility, meeting stringent regulatory requirements, and adapting to variations in raw materials are also key obstacles. Collaborating closely with quality assurance, manufacturing, and regulatory teams is vital to address these issues and develop robust, scalable processes that adhere to industry standards.

What is the difference between Cell Therapy Process Development Engineer vs Cell Manufacturing Technician?

AspectCell Therapy Process Development EngineerCell Manufacturing Technician
CredentialsBachelor's or Master's in Biotechnology, Bioengineering, or related fields; experience in cell culture and process developmentHigh school diploma or associate degree; on-the-job training in manufacturing processes
Work EnvironmentLaboratories, R&D settings, process optimization labsManufacturing floors, cleanrooms, production facilities
Industry UsageResearch, process development, scale-up activities in biotech and pharma companiesProduction, batch manufacturing, quality control in cell therapy manufacturing plants

The Cell Therapy Process Development Engineer focuses on developing and optimizing processes in labs, requiring advanced degrees and specialized skills. In contrast, the Cell Manufacturing Technician works on executing manufacturing processes on the production floor, often with less formal education. Both roles are essential in the cell therapy industry but differ in responsibilities, environment, and expertise level.

What are popular job titles related to Cell Therapy Process Development Engineer jobs?

For Cell Therapy Process Development Engineer jobs, the most frequently searched job titles are:

Infographic showing various Cell Therapy Process Development Engineer job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 1% As Needed, 81% Full Time, 15% Part Time, and 2% Contract. Highlights an 85% Physical, 3% Hybrid, and 12% Remote job distribution, with an average salary of $101,612 per year, or $48.9 per hour.

Process Development Engineer

Dorado, PR • On-site

Technical and Engineering Consulting
See more jobs at Technical and Engineering Consultingexternal

Full-time

Re-posted 7 days ago

Job description

About the Role

We are seeking an experienced Process Development Engineer to support the development, validation, optimization, and implementation of manufacturing processes within a highly regulated manufacturing environment. The selected professional will collaborate with cross-functional teams to develop robust manufacturing processes, qualify equipment, generate technical documentation, and support new product introductions while ensuring compliance with FDA and quality system requirements.

This position is ideal for engineers who enjoy working in fast-paced manufacturing environments where technical problem solving, continuous improvement, and process innovation are critical to success.

Key Responsibilities
  • Lead and support equipment qualification activities including IQ, OQ, PQ, and Process Performance Qualification (PPQ).
  • Develop validation protocols, reports, and Master Validation Plans.
  • Design and implement in-process and receiving inspection systems for new products and manufacturing processes.
  • Prepare technical documentation including:
    • Equipment evaluations
    • Preventive Maintenance (PM) procedures
    • Calibration procedures
    • Manufacturing work instructions
  • Manage process development projects from concept through implementation.
  • Partner with Manufacturing, Quality, Engineering, Automation, and Operations teams to ensure successful project execution.
  • Apply engineering tools including:
    • Design of Experiments (DOE)
    • PFMEA
    • Risk Analysis
    • Root Cause Investigations
  • Support process characterization, optimization, troubleshooting, and continuous improvement initiatives.
  • Work with advanced manufacturing technologies including:
    • Laser welding
    • Heat bonding
    • Injection molding
    • Vision inspection systems
    • Automated equipment (PLC, Servo Systems, Pneumatics, Sensors)
  • Support New Product Introduction (NPI) and process scale-up activities.
  • Ensure compliance with FDA regulations, GMP requirements, and company quality systems.
Minimum Qualifications
  • Bachelor's Degree in Mechanical Engineering or Electrical Engineering.
  • 5-7 years of manufacturing or quality engineering experience within an FDA-regulated industry.
  • Experience in Medical Devices, Pharmaceutical, Biotechnology, or Diagnostics manufacturing.
  • Strong knowledge of:
    • Equipment Qualification (IQ/OQ/PQ)
    • Process Validation
    • DOE
    • PFMEA
    • CAPA
    • Root Cause Analysis
  • Experience developing technical documentation and validation deliverables.
  • Working knowledge of:
    • 21 CFR Part 820
    • GMP
    • ISO 13485
  • Experience supporting automated manufacturing equipment and production systems.
Preferred Qualifications
  • Experience supporting New Product Introduction (NPI).
  • Experience with automated manufacturing technologies.
  • Knowledge of tooling, fixtures, and test method development.
  • Strong project management and technical leadership skills.
  • Excellent communication and cross-functional collaboration abilities.
What We're Looking For

The ideal candidate is:

  • Analytical and detail-oriented
  • Strong technical problem solver
  • Self-driven and proactive
  • Comfortable working with multidisciplinary teams
  • Committed to quality and continuous improvement
  • Able to manage multiple priorities in a fast-paced manufacturing environment
Quality Commitment

The selected candidate will demonstrate a strong commitment to patient safety, product quality, regulatory compliance, and documentation excellence while supporting all applicable Quality System requirements.

Apply