Manufacturing Support Technician I (GMP Cleaning & Parts Support)

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