Senior Regulatory Science Specialist

GForce Life Sciences; Mahwah (NJ); On-site; USD 75,000 - 110,000; Full time

Job summary

GForce Life Sciences in Mahwah, NJ is seeking a Senior Specialist, Regulatory Science for an onsite 18-month contract. You will provide technical support for sterile/regulated product transfers and contribute to process monitoring programs.

Responsibilities include writing and reviewing protocols and validation documents, coordinating with labs and vendors, and ensuring compliance with cGMPs and regulatory standards. Strong communication and multitasking are essential.

Qualifications

• Bachelor’s degree required in biology, microbiology, biomedical engineering, toxicology or related field.
• 2–4 years of experience in a regulated environment (medical device/pharma/biotech) supporting microbiology, sterilization, or sterility assurance.
• Experience writing and reviewing technical documentation (test plans, protocols, validation docs, assessments, reports).
• Working knowledge of cGMPs, USP/ISO-based test methods, standard lab techniques, safety procedures, and Good Documentation Practices.

Responsibilities

• Provide technical support for product transfers involving sterile/regulated healthcare products and assist with ongoing process monitoring.
• Support sterilization process validations and microbiological assessments tied to transfers and lifecycle sustainment.
• Author/review/approve protocols, validation documentation, technical assessments, and final reports.
• Coordinate with cross-functional partners and external vendors to align on requirements, risks, results and timelines.
• Support environmental monitoring activities and testing coordination per procedures and regulations.
• Analyze and trend monitoring data; support investigations for out-of-specification or nonconforming results.
• Maintain accurate records in line with Good Documentation Practices; operate/maintain lab equipment and perform minor troubleshooting.

Skills

cGMP knowledge

ISO/USP methods

Technical writing

Communication skills

Lab techniques

Education

Bachelor’s degree in Biology or related field

Tools

Lab equipment

Job description

Senior Specialist, Regulatory Science

18- month Contract

Onsite in Mahwah, NJ

Must be able to work on a W2

Key Responsibilities

• Provide 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.

Qualifications

• Bachelor’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.