R&D Microbiology Technologist

Job Summary: The R&D Microbiology Technologist plays a crucial role in developing procedures and processes for new microbiological transport system products. Responsible for ensuring  products meet FDA 510(k) clearance. This position is in Guilford, ME and reports to the Production Manager.

Duties/Responsibilities: 

• Ensures product meets applicable testing standard for medical device requirements for FDA 510k submissions.
• Creates and/or assembles all applicable documentation required for FDA 510(k) submission.  
• Research and development of new products: medium formulations, component qualifications, and functionality of overall product.  
• Performs chemical validations to ensure chemical(s) meet testing requirements.
• Maintain records for FDA 510(k) submissions, R&D data, SOP, production forms, etc. 
• Validates equipment for use prior to being used in production.
• Perform annual calibration certification on equipment for production.
• Performs analysis on bacterial recovery, product shelf-life results, and accelerated shelf-life.  
• Create and maintain new standard operating procedures and training materials for new product processes. 
• Production process development: Using SOP’s written, develop overall process of product manufacture.
• Inspect raw material, in-process material, and finished good.
• Test performance and document results on applicable finished goods to ensure product specifications are met. 
• Maintain and update the MSDS  for all chemicals received.  
• Evaluates data and writes reports based off technical testing.  
• Recommend and  modify existing quality or production procedures to achieve optimum quality.
• Other duties as assigned.

Key Skills Required:

• Must be detail oriented, organized, and able to make good decisions while adhering to deadlines.
• Able to communicate clearly and concisely  both verbally and written. 
• Basic computer and Microsoft Office software knowledge 

Education and Experience:

• High School Diploma. College degree or coursework in biology field preferred
• Basic laboratory and aseptic techniques experience preferred

Physical Requirements:

• Must be able and willing to work in a fast-paced environment.
• Must be able to use fingers to grasp, move, or assemble very small objects.
• Must be able to lift up to 15 pounds.
• Ability to move around the lab efficiently, including bending, reaching, standing or sitting for extended periods.

Note: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Duties, responsibilities, and activities may change or added at any time or without notice.

Disclaimer:

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice. Puritan Medical Products Company is An Equal Opportunity/Affirmative Action Employer. All qualified applicants and employees for hiring, placement and advancement will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or military status, age, or any other federally protected class.