Supervisor, Manufacturing GMP Cleaning and Sanitization

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

JOB SUMMARY

The Supervisor, Manufacturing, GMP Cleaning and Sanitization is responsible for supervising and ensuring the thorough and compliant execution of cleaning and sanitization activities in a regulated GMP environment. The role oversees the team responsible for maintaining cleanliness and aseptic conditions across production areas, ensuring that all activities adhere to Standard Operating Procedures (SOPs) and regulatory requirements.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Supervise and coordinate routine and scheduled cleaning and sanitization of cleanrooms, production areas, and equipment, ensuring strict adherence to GMP guidelines and SOPs.

• Review and verify documentation related to cleaning and sanitization and operations activities for completeness, accuracy, and compliance with regulatory and company standards.

• Conduct and oversee inspections of sanitized areas to ensure cleanliness, and ongoing GMP compliance.

• Manage inventory and procurement of facility supplies (e.g., gowns, disinfectants, wipes), ensuring uninterrupted operation of GMP areas and minimizing downtime.

• Partner with Quality Assurance to maintain audit readiness and support the continuous improvement of cleaning protocols and compliance procedures.

• Lead preparation efforts for internal and external audits and inspections, ensuring all documentation and processes within compliance.

• Ensure team adherence to safety protocols, including proper chemical handling, waste disposal, and equipment use, and enforce documentation and compliance tracking via internal systems.

• Oversee the safe transport and traceability of parts between departments, ensuring procedures align with GMP/GDP standards.

• Monitor and supervise sanitization of parts, including washing and sterilization processes, ensuring consistency with cleanliness and safety standards.

• Ensure proper operation of autoclave equipment, providing training and oversight to staff, and confirming sterilization practices meet GMP requirements.

• Oversee the assembly and kitting of parts, verifying accuracy, timeliness, and proper delivery to production areas.

• Review and approve documentation for part transport, cleaning, autoclaving, and delivery activities, ensuring full compliance with regulatory requirements.

• Foster cross-functional collaboration, acting as a liaison between production, quality, and facilities to ensure seamless daily operations and resolution of issues.

• Monitor supply levels and equipment performance, coordinating timely replenishment and maintenance to support efficient and uninterrupted operations.

SKILLS

• Lead, mentor, and manage a team of GMP cleaners and sanitizers on night shift.

• Ensure all team members are trained and compliant with SOPs and GMP regulations.

• Schedule and oversee daily cleaning tasks and ensure efficient workflow management.

• Act as the primary point of contact for the team, handling escalations and issues as they arise.

QUALIFICATIONS

Required:

• BS/BA degree with 5+ years of industry experience. Equivalent education and experience may substitute for stated requirements.

Physical Requirements:

• Must be able to perform aseptic gowning and work in a clean room environment.

• Must be able to lift/carry up to 40 pounds and complete required paperwork.

• Must be able to sit and stand for extended periods.

• Must be available to work twelve-hour shift

SCHEDULES

Front Half Days – Sunday to Wednesday, 6am to 4:30pm 

Back Half Days – Wednesday to Saturday, 6am to 4:30pm 

COMPENSATION

$94,000-$117,500

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commi