Senior Microbiology & Sterilization Scientist (Regulatory)

Actalent; Mahwah (NJ); On-site; USD 55,000 - 78,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Health Spending Account (HSA)

PTO / Vacation

Job summary

Actalent is seeking a Senior Specialist, Regulatory Science to support product transfers for orthopedic medical devices, with a focus on sterilization, microbiology, and regulatory compliance. The role collaborates with internal teams and external labs to ensure cGMP adherence and robust documentation.

The ideal candidate has hands-on experience in sterilization validation, environmental monitoring, and technical documentation within a regulated medical device setting, and will support ongoing

Qualifications

• Hands-on experience in sterilization validation, microbiological testing, and environmental monitoring.
• Experience authoring and reviewing protocols, validation reports, and technical assessments.
• Experience with cGMP and GDP in regulated environments.

Responsibilities

• Support sterilization validations and microbiological assessments for product transfers and lifecycle activities.
• Coordinate with cross-functional teams, labs, and vendors to communicate results and risks.
• Perform or coordinate microbiological testing in compliance with procedures and regulatory requirements.
• Analyze environmental monitoring data and investigate OOS events.
• Maintain laboratory equipment and ensure preventive maintenance.
• Document in accordance with cGMP and GDP.

Skills

Sterilization Validation

Microbiological Testing

Environmental Monitoring

cGMP

USP Standards

Protocol & Report Authoring

Education

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

Job description

Actalent is seeking a Senior Specialist, Regulatory Science to support product transfers for orthopedic medical devices, with a focus on sterilization, microbiology, and regulatory compliance. The role collaborates with internal teams and external labs to ensure cGMP adherence and robust documentation.

The ideal candidate has hands-on experience in sterilization validation, environmental monitoring, and technical documentation within a regulated medical device setting, and will support ongoing