Clean Room Supervisor - 2nd Shift

Cleanroom Supervisor – 2nd Shift (3:00 PM – 11:30 PM)

About SaniSure

SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today’s most innovative and life-changing medicines.

As we continue to expand our product offerings and global footprint, SaniSure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry.

Job Summary

The Cleanroom Supervisor – 2nd Shift is responsible for the hands-on supervision of daily cleanroom operations during the 3:00 PM–11:30 PM shift, ensuring production targets are met while upholding the highest standards of cleanliness, product quality, safety, and compliance. This role provides frontline leadership to Cleanroom Assemblers, supporting the site in scheduling, training, performance management, and continuous improvement initiatives.

Essential Functions

• Provide day-to-day supervision, coaching, and mentorship to Cleanroom Assemblers on 2nd shift (3:00 PM–11:30 PM); foster a culture of accountability, engagement, and continuous improvement.
• Lead by example in upholding cleanroom standards, gowning procedures, contamination control measures, and safety protocols.
• Assign daily tasks, set priorities, and monitor workflows to achieve maximum production efficiency during the 2nd shift.
• Monitor team performance and attendance; address performance, conduct, or attendance issues in a timely and constructive manner.
• Interview, onboard, and train new cleanroom personnel assigned to 2nd shift.
• Deliver and document hands-on training for cleanroom 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 and escalate quality or compliance issues promptly; assist in developing and executing corrective actions.
• Recommend process improvements and efficiency enhancements within the cleanroom; 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 cleanroom environment.
• Maintain a clean, organized, and inspection-ready cleanroom 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 to Operations management and cross-functional partners including Warehouse, Planning, Quality, Engineering, and Supply Chain; ensure proper shift handoff documentation at end of 2nd shift.
• Participate in production meetings and contribute to cross-departmental coordination as needed.
• Perform other duties as assigned.

Education

• 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 cleanroom 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 cleanroom protocols, contamination control standards, and precision assembly techniques.
• Ability to manage multiple priorities and meet deadlines in a 2nd shift environment.
• Ability to read and interpret technical drawings, BoMs, work orders, and SOPs 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.
• Patient, tactful, and approachable; able to remain calm and constructive in challenging situations.
• Self-motivated with excellent follow-up skills; able to work independently and as part of a team.

Equal Employment Opportunity Policy

We are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion (including religious dress and grooming practices), color, sex (including childbirth, breast feeding, and related medical conditions), gender identity or expression, sexual orientation, national origin, citizenship status, uniform service member status, pregnancy, age (40 and over), genetic information, disability (mental and physical), or any other protected status in accordance with all applicable federal, state, and local laws.