Cleanroom Technician

GMP Assembly Technician 1st Shift

This role focuses on hands-on assembly, testing, troubleshooting, and rework of system builds in a highly regulated GMP production environment. You will collaborate closely with other assembly associates to support integration testing, develop manual work instructions, and refine production processes to ensure a high-quality, safe, and efficient operation.

Responsibilities:

• Coordinate daily with assembly associates to support integration testing, manual instruction development, and production process development, ensuring a consistent and high-quality process.
• Perform hands-on assembly, testing, and troubleshooting of system builds and rework in a regulated production setting.
• Work from documented procedures, follow established work instructions, and accurately maintain quality data and production records.
• Maintain the integrity, organization, and cleanliness of work areas in accordance with GMP and cleanroom standards.
• Ensure adherence to all safety policies and procedures while working with equipment, materials, and chemicals.
• Handle, label, and dispose of hazardous chemicals properly, following all regulatory and facility guidelines.
• Share knowledge and train co-workers and new employees on assembly techniques, procedures, and best practices.
• Establish effective working partnerships with other departments to promote strong communication and facilitate the transfer of knowledge and experience.
• Support production inspection activities to help maintain product quality and compliance.
• Operate relevant production and assembly machinery and equipment as required.
• Perform other duties as assigned to support production goals and continuous improvement initiatives.

Essential

Skills:

• 23 years of experience performing assembly in a GMP production environment.
• 23 years of experience documenting product information and maintaining accurate production and quality records.
• 23 years of experience performing labeling activities in a regulated environment.
• 23 years of experience working with hand tools in an assembly or production setting.
• Experience with production and assembly processes in a regulated environment.
• Experience following and contributing to work instructions and documented procedures.
• Familiarity with GMP and FDA-regulated production standards.
• Ability to perform production inspection tasks to ensure product quality.
• Strong attention to detail and commitment to maintaining high-quality standards.
• Ability to work collaboratively with cross-functional teams and share knowledge effectively.

Additional Skills &

Qualifications:

• Experience working in a cleanroom environment.
• Experience in medical or pharmaceutical device production is preferred.
• Experience in medical assembly or working with medical devices.
• Experience operating production and assembly machinery.
• Comfort working in a highly regulated, process-driven environment.
• Ability to follow detailed work instructions and standard operating procedures.
• Strong communication skills for training and knowledge transfer.

Why Work Here?

You will contribute to work that directly improves patient care and impacts lives in a meaningful way. The organization operates on a global scale, giving you the opportunity to collaborate with colleagues from around the world and participate in innovative healthcare solutions at the forefront of the diagnostic industry. The culture emphasizes diversity and inclusion, valuing each person’s unique perspective and fostering a supportive, collaborative environment where everyone can thrive.

If you are passionate about innovation, diversity, and making a positive impact on healthcare, you will find an engaging and purpose-driven workplace with opportunities to grow, embrace new challenges, and help shape the…