Sterilization Project Lead – Med Devices (EtO/Gamma)

Matlen Silver; Mahwah (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Matlen Silver is seeking a Project Manager - Sterilization for an 18-month contract in Mahwah, NJ (onsite). The role focuses on transferring products from external suppliers to internal facilities, with cross-functional collaboration across microbiology, sterilization, and regulatory teams.

The ideal candidate has experience with Gamma and EtO sterilization, ISO 11135, and cGMP, and will lead validation, testing, data review, and documentation for lifecycle sustainment of sterile medical devices.

Qualifications

• Bachelor’s degree in Biology, Microbiology, Biomedical Engineering, Toxicology, or a related scientific discipline.
• 2–4 years in a regulated healthcare environment supporting microbiology, sterilization, or sterility assurance 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.

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.

Skills

Gamma and EtO sterilization

ISO 11135

cGMP knowledge

Technical documentation

Education

Bachelor's degree in Biology, Microbiology, Biomedical Engineering, Toxicology, or related

Job description

Matlen Silver is seeking a Project Manager - Sterilization for an 18-month contract in Mahwah, NJ (onsite). The role focuses on transferring products from external suppliers to internal facilities, with cross-functional collaboration across microbiology, sterilization, and regulatory teams.

The ideal candidate has experience with Gamma and EtO sterilization, ISO 11135, and cGMP, and will lead validation, testing, data review, and documentation for lifecycle sustainment of sterile medical devices.