Englewood, Colorado, United States
7 hours ago
Microbiologist/Technical Writer - Temporary

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. 

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards.  We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.


What You Can Expect

Paragon 28, a Zimmer Biomet company,  is seeking a detail-oriented and scientifically driven Microbiologist – Technical Writer to support technical documentation needs across our microbiology, validation, and quality systems teams. This role will serve as a key contributor to the generation of clear, compliant, and scientifically accurate documentation for medical device development, validation, and regulatory submissions.  This is a temporary hourly position and can be remote for residents of the United States.  

How You'll Create Impact Write and revise microbiological risk assessments, including bioburden, sterility assurance, and contamination control strategies.Author technical reports, including product release justifications, test summaries, and data interpretation.Draft and maintain validation reports for equipment, processes, and methods related to microbiological controls.Generate adoption reports for new materials, processes, and suppliers requiring microbiological evaluation.Prepare test reports and protocol summaries in alignment with regulatory and internal quality requirements.Act as a technical resource on CAPAs, nonconformances, and deviation investigations with microbiological implications as well as for cross-functional document reviews, audits, and process improvements.Support development and maintenance of documentation in compliance with EU MDR Annex I and other global regulatory standards.Collaborate with cross-functional teams (Quality, Regulatory, R&D, Lab) to ensure microbiological control and documentation accuracy.Assist during internal and external audits by providing documentation and microbiological expertise.Ensure all documentation adheres to Paragon 28’s standards for technical writing, formatting, and controlled document systems.Your Background Bachelor’s degree in Microbiology, Biology, or a related scientific field2–5 years of experience in microbiology or medical device/pharma quality assurance environments.Proven and evidenced experience in technical writing for regulated industries, preferably medical device, biotech, and/or pharma.Ability to interpret and present scientific data for technical and non-technical audiences.Familiarity with 21 CFR 820, ISO 13485, EU MDR, and ISO/AAMI standards relevant to cleaning and sterilization validations Strong organizational and project management skills with the ability to handle multiple priorities.Excellent written and verbal communication skills with high attention to detail.

Preferred Skills:

Experience with electronic document control systems.Prior audit or inspection experience (e.g., FDA, Notified Bodies).Familiarity with cleanroom microbiology and environmental monitoring concepts.Compensation Data

Hourly Rate Range:  $40.00-50.00 USD per hour worked


EOE

Por favor confirme su dirección de correo electrónico: Send Email