Senior Regulatory Science Specialist

Senior Specialist, Regulatory Science18- month ContractOnsite in Mahwah, NJMust be able to work on a W2Key ResponsibilitiesProvide technical support for a product transfer initiative involving sterile/regulated healthcare products, with secondary support for an ongoing process monitoring program.Support sterilization process validations and microbiological assessments tied to transfers, manufacturing changes, and lifecycle sustainment.Author/review/approve protocols, validation documentation, technical assessments, and final reports.Coordinate with cross-functional partners and external vendors (e.g., testing labs, contract service providers, suppliers) to align on requirements, risks, results, and timelines.Support environmental monitoring activities, including testing coordination/execution per procedures and regulations.Analyze and trend monitoring data; support investigations for out-of-specification/nonconforming results.Maintain accurate records in line with Good Documentation Practices; operate/maintain lab equipment and perform minor troubleshooting.QualificationsBachelor’s degree in Biology, Microbiology, Biomedical Engineering, Toxicology, or related scientific discipline.2–4 years of experience in a regulated environment (medical device/pharma/biotech or similar) supporting microbiology, sterilization, or sterility assurance for sterile products.Experience writing and reviewing technical documentation (test plans, protocols, validation documentation, assessments, reports).Working knowledge of cGMPs, USP/ISO-based test methods, standard lab techniques, safety procedures, and Good Documentation Practices.Strong communication skills and ability to manage multiple priorities with minimal supervision.Preferred: familiarity with relevant sterilization/regulatory standards (e.g., ISO 11135/11137), product transfers, and working with external labs/service providers.