Supervisor, Manufacturing GMP Cleaning and Sanitization

AGC Biologics, Inc.; Bothell (WA); On-site; USD 94,000 - 118,000; Full time

Job summary

AGC Biologics, Inc. is seeking a Supervisor for Manufacturing GMP Cleaning and Sanitization in Bothell. The role oversees the cleaning processes in a regulated environment, ensuring compliance with industry standards and managing a team. Ideal candidates hold a BS/BA degree with relevant industry experience and demonstrate strong leadership and organizational skills in maintaining cleanliness and safety standards.

Qualifications

• 5+ years of experience in a GMP regulated environment.
• Experience managing a team.
• Ability to conduct thorough inspections and ensure compliance.

Responsibilities

• Supervise cleaning and sanitization of cleanrooms and production areas.
• Ensure compliance with GMP standards and SOPs.
• Manage inventory and procurement of essential supplies.

Skills

Team Leadership

GMP Compliance

Documentation Review

Safety Protocols

Education

BS/BA degree

Job description

Supervisor, Manufacturing GMP Cleaning and Sanitization page is loaded

Supervisor, Manufacturing GMP Cleaning and Sanitization

Apply locations Bothell, Washington, USA time type Full time posted on Posted 9 Days Ago time left to apply End Date: June 20, 2025 (11 days left to apply) job requisition id JR102027

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 commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook !

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

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About AGC Biologics

AGC Biologics is a leading global biopharmaceutical Contract Developmentand Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com .