Manufacturing Support Technician I (GMP Cleaning & Parts Support)

Manufacturing Support Technician I (GMP Cleaning & Parts Support)

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 Manufacturing Support Technician I (GMP Cleaning & Parts Support) will be responsible for performing GMP cleaning, sanitization, parts washing, autoclaving, and kitting to support manufacturing operations. This role ensures that both cleanroom areas and parts meet regulatory requirements and operational needs while adhering to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

Essential Job Duties/Responsibilities

• Perform routine and scheduled cleaning and sanitization of cleanrooms, production areas, and equipment according to GMP guidelines and SOPs.
• Accurately document all cleaning and sanitization activities to ensure records are complete, up-to-date, and compliant with regulatory requirements.
• Conduct inspections of sanitized areas to ensure cleanliness and compliance with GMP standards.
• Order and restock necessary facility supplies (e.g., gowns, disinfectants, wipes) and monitor inventory to ensure continuous operation of GMP areas.
• Work closely with the Quality Assurance team to ensure cleaning protocols are audit-ready and in compliance with regulations.
• Assist in the preparation for facility inspections and audits.
• Follow safety protocols related to chemical handling, waste disposal, equipment use, and proper documentation and compliance tracking through internal systems.
• Safely transport parts between departments, ensuring proper handling and traceability to maintain GMP/GDP compliance.
• Wash and sanitize parts according to GMP guidelines, ensuring that all parts meet cleanliness and safety standards.
• Operate autoclave equipment to sterilize parts in compliance with GMP procedures.
• Prepare, assemble, and deliver parts into kits, ensuring all items are correctly grouped, packaged, and delivered to designated areas in a timely and accurate manner.
• Ensure parts are handled safely and meet required specifications for further processing.
• Complete all required documentation for the transportation, washing, autoclaving, and delivery of parts, ensuring compliance with GMP/GDP regulations.
• Collaborate with team members and other departments to ensure smooth operations and adherence to all production and quality requirements.
• Continuously monitor and maintain cleaning supplies and parts handling equipment, requesting replenishment as needed.
• Follow all established SOPs, safety guidelines, and quality standards related to cleaning, parts handling, and operations.

Skills

• Identifies and resolves semi-routine and recurring problems within own work area.
• Evaluates and selects solutions from established operating procedures.
• Uses communication skills to exchange information and escalate issues.
• Demonstrates strong written and verbal communication skills.

Qualifications

Required:

• High School Diploma or equivalent.
• 0-2 years of related experience.

Preferred:

• Associate's degree/BS/BA degree preferred.

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 shifts.

Schedules

• Front Half Days – Sunday to Wednesday, 6am to 4:30pm.
• Front Half Swing - Sunday to Wednesday, 3pm to 1:30am.
• Back Half Days – Wednesday to Saturday, 6am to 4:30pm.
• Back Half Swing - Wednesday to Saturday, 3pm to 1:30am.

Compensation

$19.26-$24.09/hour

At AGC Biologics, we are always seeking dedicated and skilled Manufacturing Technicians to join our team. By maintaining this evergreen job posting, we can connect with potential candidates as new opportunities arise within our team. We actively monitor applications and continuously match candidates to available positions, ensuring that we find the right fit for both you and our organization.

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.

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.