Genesis10 is currently seeking a Technical Support Specialist - Microbiology/Sterilization for a contract position with a Global Medical Technology Company located in Mahwah, NJ. This is a 18+ month contract opportunity. This role will provide primary technical support for a product transfer project involving orthopedic medical devices, with a secondary focus on the ongoing process monitoring program. The ideal candidate will partner with cross-functional teams, external testing laboratories, and suppliers to ensure product transfer and lifecycle activities meet all microbiological, sterilization, and regulatory requirements. This position requires practical knowledge of cGMP, standard laboratory techniques, and medical device regulatory expectations.
Responsibilities: - 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
Requirements: - Bachelor's degree in Biology, Microbiology, Biomedical Engineering, Toxicology, or a related scientific discipline
- 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
Desired 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
Pay range: $38.84 - $48.84 per hour
Only candidates available and ready to work directly as Genesis10 employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, please apply! Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.
For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10: - Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years.
- The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.
- Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)
- Behavioral Health Platform
- Medical, Dental, Vision
- Health Savings Account
- Voluntary Hospital Indemnity (Critical Illness & Accident)
- Voluntary Term Life Insurance
- 401K
- Sick Pay (for applicable states/municipalities)
- Commuter Benefits (Dallas, NYC, SF, and Illinois)
For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website.
Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
