Regulatory Science Specialist

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

Regulatory Science Specialist

Location: Mahwah, New Jersey

About Our Client: Our client has built a high-trust, people-first culture driven by real employee feedback and a commitment to innovation, collaboration, and performance. Known for fostering an environment where employees feel valued, supported, and empowered to grow, the organization continues to set itself apart as an employer of choice. Working here means joining a team of top technical professionals bringing cutting-edge products to the forefront—offering driven individuals the opportunity to make a meaningful impact every day.

Key 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.

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.

JBL is an Equal Opportunity Employer and E-Verify Company