Medical Device Sterilization Specialist

Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a Medical Device Sterilization Specialist for a 12-month+ contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail-oriented Top Talents in an extremely collaborative and professional environment.  

Support onsite manufacturing of orthopedic medical devices pertaining to the sterilization and cleanliness of the devices. Familiar with cGMP, standard laboratory techniques (i.e. USP and ISO based testing methods) and safety procedures (i.e. OSHA). Knowledgeable in scientific concepts, measures, and terminology. Responsible for performing routine testing (i.e., growth promotion, total organic carbon) and environmental monitoring in compliance with established procedures and regulatory requirements. Conducts analysis of environmental and water samples, documents and trends laboratory data, supports OOS investigations, and assists with data review. Maintains laboratory equipment through calibration, preventive maintenance, and troubleshooting, while ensuring adequate laboratory supplies and quality control standards are maintained.

Key Responsibilities:

• Supporting onsite manufacturing of orthopedic medical devices by ensuring the sterilization and cleanliness of the devices.
• Familiarizing with cGMP, standard laboratory techniques (i.e., USP and ISO based testing methods), and safety procedures (i.e., OSHA).
• Demonstrating knowledge of scientific concepts, measures, and terminology.
• Performing routine testing (e.g., growth promotion, total organic carbon) and environmental monitoring in compliance with established procedures and regulatory requirements.
• Analyzing environmental and water samples, documenting and trending laboratory data, supporting OOS investigations, and assisting with data review.
• Maintaining laboratory equipment through calibration, preventive maintenance, and troubleshooting, while ensuring adequate supplies and quality control standards are met.
• Conducting routine microbiological laboratory testing and process monitoring in accordance with methods, protocols, and regulatory requirements.
• Performing laboratory analysis of environmental and water samples and identifying microorganisms according to defined procedures.
• Maintaining accurate records of work performed and documenting results in accordance with GDP and established procedures.
• Performing data entry required for trending analysis.
• Assisting with the review of worksheets, as assigned.
• Supporting the investigation of OOS results within assigned responsibility areas.
• Operating and maintaining laboratory equipment, ensuring reliability through executing preventive maintenance, routine performance, and calibration checks; demonstrating the ability to troubleshoot minor issues.
• Maintaining laboratory supplies, including order placement and QC checks.
• Preparing solutions and mixtures for testing and analysis.

What you need

• Bachelor's degree in Biological Sciences or a related field.
• Minimum of 2 years' experience in a QC microbiology laboratory environment, particularly in regulated manufacturing settings such as medical devices or pharmaceuticals.
• Excellent manual dexterity and keen attention to detail.
• Proven ability to complete sampling and testing assignments accurately and efficiently.
• Strong understanding of cGMPs and compendia testing protocols.
• Effective verbal and written communication skills.
• Ability to handle multiple projects simultaneously with minimal supervision.
• Experience with routine microbiological testing, environmental monitoring, and analysis of water samples.
• Familiarity with laboratory safety procedures and equipment calibration.