Manufacturing Process Engineer II

Katalyst-Healthcares-; California; On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst-Healthcares- is seeking a Manufacturing/Process Engineer to partner with Manufacturing and R&D to optimize processes and support tech transfer from product development into manufacturing.

The role emphasizes troubleshooting equipment, improving filtration-related processes, and delivering SOPs, validation docs, and training materials; requires hands-on mechanical skills, GMP experience, and strong cross-functional collaboration.

Qualifications

• Bachelor's degree in Engineering or equivalent.
• 3–8 years of engineering experience in a manufacturing or process development environment.
• Strong hands-on mechanical aptitude and troubleshooting skills.
• Experience with process improvement, equipment validation, and project execution.
• Excellent communication and cross-functional collaboration skills.
• Biopharmaceutical manufacturing or medical device manufacturing.
• Filtration systems, TFF, pumps, pressure tanks, UV detectors, and process equipment.
• Technology transfer, process scale-up, and new product introduction.
• GMP manufacturing and cleanroom environments.

Responsibilities

• Partner with Manufacturing and R&D to implement and optimize manufacturing processes.
• Support technology transfer from Product Development into Manufacturing.
• Troubleshoot manufacturing equipment and resolve process-related issues.
• Improve processes involving filtration products and systems.
• Develop SOPs, validation documentation, technical reports, and training materials.
• Lead root cause investigations, corrective actions, and continuous improvement projects.
• Collaborate with cross-functional teams to meet production and quality objectives.

Skills

Mechanical troubleshooting

Cross-functional collaboration

Biopharma/medical devices

GMP/cleanroom

Education

Bachelor's degree in Engineering or equivalent

Tools

Filtration systems

TFF

Pumps

Pressure tanks

UV detectors

Process equipment

Job description

Roles and Responsibilities:

• Partner with Manufacturing and R&D to implement and optimize manufacturing processes.
• Support technology transfer from Product Development into Manufacturing.
• Troubleshoot manufacturing equipment and resolve process-related issues.
• Improve processes involving filtration products and systems.
• Develop SOPs, validation documentation, technical reports, and training materials.
• Lead root cause investigations, corrective actions, and continuous improvement projects.
• Collaborate with cross-functional teams to meet production and quality objectives.

Education and experience:

• Bachelors degree in Engineering or equivalent.
• 3–8 years of engineering experience in a manufacturing or process development environment.
• Strong hands-on mechanical aptitude and troubleshooting skills.
• Experience with process improvement, equipment validation, and project execution.
• Excellent communication and cross-functional collaboration skills.
• Biopharmaceutical manufacturing or medical device manufacturing.
• Filtration systems, TFF, pumps, pressure tanks, UV detectors, and process equipment.
• Technology transfer, process scale-up, and new product introduction.
• GMP manufacturing and cleanroom environments.