Sterilization & Microbiology Regulatory Scientist

JBL Resources; Mahwah (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

JBL Resources in Mahwah, New Jersey seeks a Regulatory Science Specialist to support sterilization validations, microbiological assessments, and lifecycle sustainment of sterile products. This role involves authoring and reviewing protocols and coordinating with cross-functional teams and external labs to ensure compliance with regulatory standards.

The successful candidate will monitor environmental data, conduct testing per approved procedures, and help document results under cGMP, USP-, and

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 documents, technical assessments, or final reports.
• Experience with terminal sterilization technologies, sterilization validation, microbiological testing, and biological testing strategies.
• Working knowledge of cGMP requirements, laboratory techniques, USP- and ISO-based testing methods, Good Documentation Practices, and applicable safety procedures.
• Ability to manage multiple assignments, communicate technical information clearly, and complete work accurately with minimal supervision.

Responsibilities

• Supporting sterilization process validations and microbiological assessments associated with product transfers, manufacturing changes, and product lifecycle sustainment.
• Authoring, reviewing, and approving protocols, validation documentation, technical assessments, and final reports evaluating compliance with applicable microbiological and sterilization requirements.
• Coordinating technical activities with cross‑functional partners, external testing laboratories, contract sterilizers, and suppliers while clearly communicating requirements, results, risks, and project status.
• Supporting the ongoing environmental monitoring program by conducting or coordinating microbiological testing in accordance with approved procedures and regulatory requirements.
• Performing and supporting the analysis, review, and trending of environmental monitoring data.
• Supporting investigations of out‑of‑specification and other nonconforming results within assigned areas.
• Operating and maintaining laboratory equipment, completing required preventive maintenance, and troubleshooting minor equipment issues.
• Maintaining complete and accurate records of work performed and documenting results in accordance with Good Documentation Practices and established procedures.

Skills

Microbiology experience

Documentation authoring

Regulatory knowledge

Cross-functional teamwork

Education

Bachelor's degree in Biology / Microbiology / Biomedical Engineering / Toxicology

Job description

JBL Resources in Mahwah, New Jersey seeks a Regulatory Science Specialist to support sterilization validations, microbiological assessments, and lifecycle sustainment of sterile products. This role involves authoring and reviewing protocols and coordinating with cross-functional teams and external labs to ensure compliance with regulatory standards.

The successful candidate will monitor environmental data, conduct testing per approved procedures, and help document results under cGMP, USP-, and