Clean Room Engineer Jobs in California (NOW HIRING)

About the Company:

As the go-to Single Use Technologies (SUT) experts, SaniSure offers unparalleled expertise in complex flow paths and closed systems design, in support of our customer's most demanding bioprocessing and advanced therapies workflows.

SaniSure provides a uniquely diversified and vertically integrated portfolio of highly innovative proprietary solutions, custom assemblies, and engineered components. By applying our deep product and application expertise in a consultative manner, we work with our customers to resolve their most challenging flow path needs, supported by our industry-leading, in-house design and manufacturing capabilities.

While larger companies cannot offer the flexibility, and smaller companies lack the depth of capabilities, SaniSure stands apart as the best of both worlds—unmatched flexibility combined with end-to-end capabilities and deep vertical integration to help our customer's de-risk, grow and innovate.

SaniSure is a growing biopharma company with a genuine collaborative culture — the kind where you know your colleagues, your work is visible, and your ideas get heard. We design and manufacture single-use solutions that play a direct role in how life-saving therapies reach patients.

About the Role:

The Clean Room Supervisor is responsible for the hands-on supervision of daily Clean Room operations, ensuring production targets are met while upholding the highest standards of cleanliness, product quality, safety, and compliance. This role provides frontline leadership to Clean Room Assemblers, supporting the site in scheduling, training, performance management, and continuous improvement initiatives.

Essential Functions:

• Provide day-to-day supervision, coaching, and mentorship to Clean Room Assemblers; foster a culture of accountability, engagement, and continuous improvement.
• Lead by example in upholding Clean Room standards, gowning procedures, contamination control measures, and safety protocols.
• Assign daily tasks, set priorities, and monitor workflows in coordination to achieve maximum production efficiency.
• Monitor team performance and attendance, address performance, conduct, or attendance issues in timely and constructive manner.
• Interview, onboard, and training new Clean Room personnel.
• Deliver and document hands-on training for Clean Room assembly procedures, safety protocols, gowning standards, and documentation practices.
• Identify skill gaps and recommend training opportunities to support team member development and production readiness.
• Oversee the preparation and assembly of parts and products in accordance with work orders, SOPs, technical drawings, Bills of Materials (BoMs), and batch/lot documentation requirements.
• Ensure all forms, records, and documentation associated with each lot or batch are accurately completed by team members.
• Conduct floor-level inspections of workstations, completed assemblies, and equipment to verify ongoing compliance with cleanliness, safety, and quality control standards.
• Participate in customer complaint investigations and quality deviation responses.
• Identify, develop and execute corrective actions.
• Recommend process improvements and efficiency enhancements within the Clean Room; support the implementation and monitoring of changes, as directed.
• Enforce adherence to OSHA, cGMP, ISO 9001, and all applicable regulatory standards and internal policies within the Clean Room environment.
• Maintain a clean, organized, and inspection-ready Clean Room at all times.
• Support environmental monitoring activities, equipment calibration checks, and validation tasks in coordination with Facilities, Engineering, and Quality teams.
• Communicate production issues, trends, and priorities effectively through Operations management and cross-functional partners Warehouse, Planning, Quality, Engineering, and Supply Chain.
• Participate in daily production meetings and contribute to cross-departmental coordination, as needed.
• Perform other duties, as assigned.

Minimum Qualifications:

• Bachelor’s Degree in a relevant field (e.g., Life Sciences, Manufacturing, Business Administration, or related discipline) preferred.

Required Experience & Competencies:

• Minimum 5 years of experience in a Clean Room or regulated manufacturing environment.
• Minimum 5 years of experience in a supervisory or management role.
• Demonstrated ability to lead, train, motivate and resolve conflicts in a fast-paced production setting.
• Strong working knowledge of Clean Room protocols, contamination control standards, and precision assembly techniques.
• Able to manage multiple priorities and meet deadlines.
• Ability to read and interpret technical drawings, BoMs, work orders, and SOP's and make data-driven decisions.
• Proactive approach to identifying opportunities for improvement and driving positive change.
• Familiarity with cGMP, ISO 9001, and OSHA regulatory requirements.
• Proficiency in MS Office, experience with ERP or production management systems a plus.
• Excellent verbal and written communication skills; able to interact effectively across all organizational levels.
• Strong organizational skills and a keen attention to detail, with the ability to effectively manage multiple priorities in a fast-paced environment.
• Effective problem-solving ability with a strong sense of urgency and ownership.