Sterilization Validation SME

Sterilization Validation Engineer-Remote opportunity with potential travel

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

Job Purpose

To review our clients existing sterilization cycle and validation evidence. To get ready for a manufacturing module submission.

• Experience with EO Sterilization for products and experience with IS 11135
• Experience with physical and mechanical properties of devices in accordance with IFU-003 , including the sterilization process
• Experience with system compliance with applicable standards
• Experience with Bio Evaluation of Medical Devices
• Strong experience in Risk Management as it pertains to Biocompatibility.
• Experience with sterilization process per requirements to demonstrate and appropriate sterility assurance levels (SAL)
• Gather, Analyze and provide technical data for technical reviews.
• Author protocols and reports as necessary.
• Oversee development builds associated with the project using special work requests.
• Contribute to technical reports, validations, and qualifications by capturing experimental results.
• Build Quality in all aspects of their work by maintaining compliance to all quality requirements.
• This is not a comprehensive list of activities to be performed by a consultant. Any other tasks assigned by the client shall be performed as requested.
  
  

• Bachelor’s in engineering
• 5-10 years of Sterilization Validation experience
• Proven organization and execution skills
• Proven ability to solve technical problems and implement solutions.
• Proven leader and team player with the ability to drive tasks / projects to completion
• Strong verbal and written communication skills.
• Sponsorship/ Corp to Corp is not available for this position.