Date Posted: 10/29/2026
Hiring Organization: Rose International
Position Number: 510049
Industry: Medical Equipment & Supplies
Job Title: Medical Device Sterilization Validation & Microbiology Specialist
Job Location: Mahwah, NJ, USA, 07430
Work Model: Onsite
Shift: 8 AM - 5 PM Mon - Fri
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 7
Min Hourly Rate($): 45.00
Max Hourly Rate($): 48.00
Must Have Skills/Attributes: Healthcare, Manufacturing, Technical, Testing
Experience Desired:
Experience supporting microbiology, sterility assurance, or sterilization validation for sterile medical devices (2-4 yrs),
Experience authoring and reviewing technical documentation (2-4 yrs),
Working knowledge of cGMP requirements and standard laboratory techniques (2-4 yrs),
Experience with terminal sterilization technologies and sterilization validation (2-4 yrs)
Required Minimum Education: Bachelor’s Degree
**C2C is not available**
Job Description
Required Education:
• Bachelor’s degree in Biology, Microbiology, Biomedical Engineering, Toxicology, or a related scientific discipline.
Required Skills:
• Two to four years of experience in a medical device, pharmaceutical, biotechnology, or other regulated healthcare environment supporting microbiology, sterilization, or sterility assurance activities for sterile products.
• Experience authoring and reviewing technical documentation, including test plans, protocols, validation documentation, technical assessments, and final reports.
• Experience with terminal sterilization technologies, sterilization validation, microbiological testing, and development or application of biological testing strategies.
• Working knowledge of cGMP requirements, standard laboratory techniques, USP- and ISO-based testing methods, Good Documentation Practices, and applicable safety procedures.
• Effective written and verbal communication skills, including the ability to explain technical concepts clearly and collaborate with cross-functional teams.
• Demonstrated ability to manage multiple assignments, meet project commitments, and complete work accurately and compliantly with minimal supervision.
Preferred Skills:
• Working knowledge of applicable medical device regulations and standards, including ISO 11135, ISO 11137, AAMI guidance, FDA requirements, EU MDR, and other relevant regulatory requirements.
• Experience supporting product transfers, manufacturing site transfers, or sterilization process changes for medical devices.
• Experience working with external testing laboratories, contract sterilizers, and suppliers that support microbiological, biological safety, or sterilization activities.
• Experience with environmental or water monitoring programs, data trending, and investigation of out-of-specification results.
Position Overview:
The role will provide primary technical support for a product transfer project involving orthopaedic medical devices, with secondary responsibility for the ongoing process monitoring program. This role will partner with cross-functional teams, external testing laboratories, contract sterilizers, and suppliers to ensure that product transfer and lifecycle sustainment activities meet applicable microbiological, sterilization, and regulatory requirements.
The position requires practical knowledge of cGMP requirements, standard laboratory techniques, USP- and ISO-based testing methods, safety procedures, and medical device regulatory expectations. The individual will apply sound technical judgment to validation, testing, data review, investigations, and technical documentation while managing assignments with minimal supervision.
Medical Device Sterilization Validation & Microbiology Specialist:
• Support sterilization process validations and microbiological assessments associated with product transfer, manufacturing changes, and product lifecycle sustainment.
• Author, review, and approve protocols, validation documentation, technical assessments, and/or final reports evaluating compliance with applicable microbiological and sterilization requirements.
• Coordinate technical activities with cross-functional partners, external testing laboratories, contract sterilizers, and suppliers; communicate requirements, results, risks, and project status clearly.
• Support the ongoing environmental monitoring program by conducting or coordinating microbiological testing in accordance with approved procedures and regulatory requirements.
• Perform and support the analysis, review, and trending of environmental monitoring data.
• Support investigations of out-of-specification and other nonconforming results within assigned areas.
• Operate and maintain laboratory equipment, complete required preventive maintenance, and troubleshoot minor equipment issues.
• Maintain complete and accurate records of work performed and document results in accordance with Good Documentation Practices and established procedures.
- **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
- **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
My on-boarding with Rose was outstanding. The packets of information, the process, and great attention to detail each person gave me allowed me to get started quickly.I appreciated each person's friendly and helpful attitude.
Diana, Consultant
Each time I contacted Rose, I was completely satisfied with the great attention and customer service I received. Each person was extremely knowledgeable and patient with my concerns or questions.
Diana, Consultant
Rose is an assembly of people grounded in honesty, truth and dignity for all of its employees and contractors.
Samba, Consultant
Rose International maintained good communication during assignments and are very informative through email and phone calls.
Sade, Consultant
I believe the best thing that Rose HR has going for it is the incredible responsiveness. Everyone is very quick to reply to any concerns, and contacts the contracted employees very quickly and efficiently.
Kevin, Consultant
EMPLOYEE COMMENTS