drjobs Manufacturing Support Technician I (GMP Cleaning & Parts Support)

Manufacturing Support Technician I (GMP Cleaning & Parts Support)

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1 Vacancy
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Job Location drjobs

Bothell, WA - USA

Hourly Salary drjobs

$ 19 - 24

Vacancy

1 Vacancy

Job Description

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 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 uptodate 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 auditready 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 semiroutine 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

  • 02 years of related experience

Preferred:

  • Associates 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 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

$19.26$24.09/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.


Required Experience:

Director

Employment Type

Full-Time

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