Senior Production Operator

Overview:

We are seeking a meticulous and quality minded Senior Operations Technician that works in a production Laboratory and/or Cleanroom setting to support the manufacturing of our bone graft product families. The role includes hands-on assembly, inspection and packaging of our finish products as well as mentoring junior technicians, supporting validations and ensuring strict adherence to GMP and ISO 13485 standards. In the beginning, the role will support the validation and commencement of our new manufacturing facility in Alpharetta, Georgia. This is a full-time, on-site position.

Key Responsibilities:

• Support the commencement of our new manufacturing facility in Alpharetta, Georgia. This includes but not limited to: 
  • 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). 
• Support training of newly onboarded operators. 
• 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 & Skills:

• Education: 
  • Bachelor's degree in biology, Chemistry Engineering, Biology, or related field required.  
  • Lean Six Sigma Green Belt Certification is preferred  
• Experience: 
  • 3+ 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 within 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 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:

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

 

Pay Range$55,000—$58,000 USD

Physical Requirements and Work Conditions

The physical demands described here are repre