Description
Job Title: Project Manager - Sterilization
Duration: 18 Months contract
Location: Mahwah, NJ (Onsite)
NO C2C, ONLY W2 Due to client requirements this role is only open to USC or GC candidates
Job Summary:
Project Details:
- Focused on managing the technical sterilization and validation requirements for transferring products from external suppliers to in-house manufacturing.
- Team Composition: A mix of microbiologists and chemists within Therapy Assurance, predominantly supporting routine operations and specific transfer projects.
- Environment: The role is heavily geared toward project management rather than bench work.
- Gowning: Minimal lab support is required. When entering Class 7 environments, standard "bunny suits" and face masks are used. No specialized mask fit testing is required.
- Project Context: The core initiative involves the transition of products from an external supplier to internal facilities.
Must Haves
- Primary Focus: Experience with Gamma and Ethylene Oxide (EtO) sterilization.
- Working knowledge of ISO 11135 is preferred/required for the project's scope.
- Validation
Position Overview
The role will provide primary technical support for a product transfer project involving orthopedic 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.
Key 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.
Required Qualifications
- 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.
Preferred Qualifications
- 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.
About Matlen Silver
Experience Matters. Let your experience be driven by our experience. For more than 40 years, Matlen Silver has delivered solutions for complex talent and technology needs to Fortune 500 companies and industry leaders. Led by hard work, honesty, and a trusted team of experts, we can say that Matlen Silver technology has created a solutions experience and legacy of success that is the difference in the way the world works.
Matlen Silver is an Equal Opportunity Employer and considers all applicants for all positions without regard to race, color, religion, gender, national origin, age, sexual orientation, veteran status, the presence of a non-job-related medical condition or disability, or any other legally protected status.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at email and/or phone at: [email protected] // 908-393-8600
At The Matlen Silver Group, Inc., W2 employees are eligible for the following benefits:
- Health, vision, and dental insurance (single and family coverage)
- 401(k) plan (employee contributions only)