PBS Biotech is seeking a hands-on Senior Manufacturing Engineer who thrives in a fast-paced, collaborative environment and enjoys wearing multiple hats. This role is ideal for someone who is equally comfortable on the manufacturing floor as they are driving process improvements, developing new manufacturing solutions, and partnering cross-functionally with Engineering, Quality, and Operations. You’ll play a key role in supporting day-to-day production while also leading initiatives that enhance efficiency, scalability, and product quality.

At PBS Biotech, we design and manufacture advanced single-use bioreactor systems that support the development and production of life-saving cell therapies and biologics. Our proprietary Vertical-Wheel® technology enables scalable, high-performance cell culture solutions for the biopharmaceutical industry. As a growing organization, we value individuals who are proactive, adaptable, and motivated to make a meaningful impact—those who take ownership, roll up their sleeves, and drive results.

Responsibilities

• Support the day-to-day processes for manufacturing bioreactors and single-use components
• Execute all functions in accordance with Good Manufacturing Practices
• Manage and execute changes to processes and BOMs using the PBS change process
• Lead process improvement efforts
• Lead equipment installation efforts
• Develop new manufacturing processes in support of new products under development
• Develop clear procedures for robust manufacturing processes
• Develop and qualify fixturing to assist operators in assembling products
• Execute IQ/OQ/PQ to qualify manufacturing processes.

Qualifications

• · Bachelor’s degree in mechanical engineering, Industrial Engineering or related field.
• Strong knowledge of Good Manufacturing Practices (GMP)
• Experience with process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Experience with CAD programs
• Experience performing Tolerance Analysis
• Experience creating manufacturing procedures
• Experience with equipment manufacturing
• 5 years of experience in a manufacturing engineering role, preferably in the biotechnology, medical device, or life sciences industry.

Skills/ Abilities Pertinent to This Position

• Ability to work with CAD software
• Ability to analyze data
• Ability to perform tolerance analysis
• Ability to author engineering plans and reports
• Ability to assess and improve assembly of electro-mechanical systems
• Ability to perform assembly line balances
• Strong analytical and problem-solving skills with the ability to assess problems or issues with manufacturing equipment.
• Extensive knowledge of production principles and techniques.
• Ability to develop and document standard operating procedures (SOPs) for manufacturing processes.
• Ability to work cross-functionally with R&D, Quality, and Operations teams.

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Work Location: In person, Camarillo, CA 93012