Manufacturing Support Technician II (GMP Cleaning & Parts Support)

Our purpose is to bring hope to life by enabling lifechanging 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 uptodate 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 auditready 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

• 24 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 twelvehour 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

$21.19$26.49/hour

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 sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased 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 cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.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.