Operator

Job Description

Job Description

Overview:

We are seeking a meticulous and quality minded Operator that works in a production Laboratory and/or Cleanroom setting to support the manufacturing of our bone graft product families. The Operator will perform assembly, inspection, packaging, and documentation tasks in accordance with GMP, ISO 13485, and FDA regulations. This role is critical to ensuring product quality, traceability, and compliance throughout the production process. In the beginning, this role will support the validation and commencement of our new manufacturing facility in Alpharetta, Georgia. This is a full-time, hourly, on-site position based out of Alpharetta, GA. 

Schedule: Monday-Friday from 7:30 AM to 4 PM

Key Responsibilities:  

• Support the commencement of our new manufacturing facility in Alpharetta, Georgia. This includes but not limited to: 

• Traveling to our Bilthoven, Netherlands manufacturing location for on-the-job training and knowledge transfer.  

• Support the Execution of our IQ/OQ/PQ validation process prior to go-live of our new manufacturing 

• Support the development and continuous improvement of our training program.   

• Perform manual and semi-automated assembly of our Magnetos product family in an ISO Class 8 cleanroom and controlled lab environment. 

• Follow detailed work instructions, standard operating procedures (SOPs), and batch records accurately. 

• Operate and maintain cleanroom equipment and tools (e.g., graduated cylinders, vibration tables, scales, vacuum sealers, ovens, dispensers). 

• Perform in-process inspections to verify quality specifications. 

• Handle sterile or non-sterile packaging and labeling of finished products, ensuring lot control and traceability. 

• Maintain cleanroom gowning protocols and adhere strictly to contamination control and hygiene standards. 

• Accurately complete production documentation, including batch records, in compliance with FDA 21 CFR Part 820 and ISO 13485. 

• Report deviations, non-conformances, or equipment malfunctions to quality personnel promptly. 

• Support cleaning, calibration, and routine maintenance of equipment and cleanroom areas. 

• Collaborate with Quality, Process Development Engineering, R&D and Production teams on continuous improvement initiatives and process validations. 

Qualifications:  

• Education: 
  • Bachelor's degree in Biology, Chemistry Engineering, Biology, or related field required.  
  • Lean Six Sigma Green Belt Certification preferred 
• Experience: 
  • 0-2+ years in Operations within an ISO13485 regulated industry  
  • Experience working in an ISO 7 or ISO 8 cleanroom manufacturing process
  • Experience working with lean manufacturing principles and with in a 6S program.
• Skills:
  • Strong attention to detail and ability to follow precise work instructions.
  • Excellent communication and interpersonal abilities
  • Ability to stand for up to 8 hours/day
  • Understanding in lean methodologies, Six Sigma tools and working within a 6S program.
  • Proficiency within an ERP or MES systems, preferably in Microsoft Dynamics 365.

Travel Requirement:

• Ability to travel domestic and international

Cleanroom Requirements: Must be able to work in an ISO Class 8 cleanroom environment and comply with all applicable GMP, cleanroom, and contamination-control requirements, including restrictions on jewelry, cosmetics, and fragrances; appropriate attire that provides adequate skin coverage; and gowning requirements, including the use of gowns, gloves, hairnets, beard covers (as applicable), and shoe covers. Employees must maintain personal grooming standards that support cleanroom operations, safety, and product quality, including natural, unpolished fingernails and proper hair restraint for long hair.

Physical Requirements and Work Conditions

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Mobility & Posture : May require occasional sitting, standing, walking, climbing, reaching, bending, or stooping.
• Lifting/Carrying : May require lifting and carrying items 50 pounds or more, depending on the role.
• Manual Dexterity : Frequent use of hands and fingers for typing, writing, grasping, and operating office or job-specific equipment.
• Driving : Some roles may require the ability to operate a motor vehicle for extended periods and maintain a valid driver's license.

Specific requirements may vary by role. Contact an HR representative for details related to the position.

Our credentials

Kuros is a Swiss-headquartered biotech company, listed on the SIX Swiss Stock Exchange since 2016 (under symbol KURN). With additional operations in the Netherlands and the USA, we continue to grow our global team.

To deliver the ideal bone graft, you need the highest quality and quantity of scientific evidence behind it. We believe that this is a key differentiator for Kuros, given the urgent need to advance bone healing.

• Listing on the  SIX Swiss Exchange  under the symbol KURN since 2016
• A commercial & research footprint that spans >20 markets
• Dozens of clinical and scientific expert Advisers
• >25  orthobiologics-related  patents
• >400 patients evaluated  in Level I, randomized controlled clinical trials
• >20  well-controlled  Level I-IV clinical trials initiated , including 6 that are complete1
• Published Level I evidence published in  Spine

Kuros Biosciences is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Kuros Biosciences complies with GDPR and the California Consumer Privacy Act (CCPA). View our CCPA Notice here.