Manufacturing Support Technician II (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 II is responsible for performing GMP cleaning, sanitization, parts washing, autoclaving, and kitting, as well as compounding, buffer, and media preparation to support manufacturing operations. This role ensures cleanrooms, production areas, and parts meet GMP/GDP compliance through routine cleaning, sterilization, and accurate documentation. The technician II will follow batch records and processing steps, report deviations, and initiate corrective actions. In addition, they will provide guidance to less experienced colleagues while maintaining operational efficiency, audit readiness, and adherence to safety protocols and regulatory standards.

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 verify cleanliness and compliance with GMP standards.

• Order and restock necessary facility supplies (e.g., gowns, disinfectants, wipes), ensuring continuous operation of GMP areas.

• Collaborate with the Quality Assurance team to ensure cleaning protocols are audit-ready and in compliance with regulatory requirements.

• Assist with 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 in accordance with GMP guidelines to ensure cleanliness and safety standards are met.

• Operate autoclave equipment to sterilize parts following 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.

• Perform routine compounding, buffer preparation, and media preparation according to established protocols and SOPs.

• Follow and document processing steps on batch records and other approved attachments to ensure compliance with regulatory and operational requirements.

• Report and initiate deviations from established procedures, ensuring corrective actions are implemented as necessary.

• Provide guidance and training to less experienced colleagues, fostering a collaborative and efficient work environment.

SKILLS

• Analyzes problems that may involve a variety of issues.

• Uses factual information for problem solving and analysis.

• Explains technical information within own team in a clear and effective manner.

• Requires strong written and verbal communication skills.

QUALIFICATIONS

Required:

• High School Diploma or equivalent

• 2-4 years of related experience

Preferred:

• Associate degree or 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 Saturda