Job Description

Title: TSMS Sterility Assurance Scientist

Type: 6 month contract w/ possible extensions

Schedule: Monday–Friday 8-5

Location: Concord site Concord, NC

Expected Compensation: $40-50/hr

Start date: ASAP

Benefits: Health, Dental, Vision, PTO, & Sick Days

Responsibilities

The Sterility Assurance Scientist is a technical role that assists in the development and implementation of the site’s sterility assurance programs and provides technical guidance and expertise in environmental monitoring, contamination control, aseptic process simulations, gowning/aseptic techniques, and cleaning/sanitization strategies, including disinfectant efficacy.

The principal role develops and implements a technical agenda and provides technical leadership for the Parenteral Process Team. This individual is also expected to serve as a mentor within the TSMS team and engage in upstream and external site activities related to sterility assurance and contamination control strategies.

Key Objectives / Deliverables

Provide oversight and technical guidance for sterility assurance programs at the manufacturing floor level.

Lead or provide technical support for sterility assurance activities including but not limited to:

• Airflow Pattern Testing
• Environmental Monitoring Performance Qualifications (EMPQ)
• Aseptic Process Simulations (APS / Media Fills)
• Cleaning, Sanitization, and Disinfection Programs
• Gowning within GMP Classified Areas
• Aseptic Processing Techniques
• Contamination Control

Additional responsibilities include:

• Assist in the development and implementation of facility monitoring and contamination control processes.
• Support development and implementation of the site contamination control strategy.
• Provide technical expertise related to cleaning and sanitization programs and disinfectant efficacy strategies.
• Support development and execution of cleanroom gowning and aseptic technique programs.

Sterility Assurance Program Support

Provide technical oversight for one or both of the following programs:

Environmental Monitoring (EM)

• Author Environmental Monitoring Performance Qualification protocols (EMPQ) and oversee execution.
• Evaluate EM data and author EM trend reports.
• Identify facility environmental isolates and maintain environmental isolate cultures.

Aseptic Process Simulation (APS / Media Fill)

• Author APS protocols and oversee execution.
• Evaluate APS data including personnel qualification results and author APS reports.
• Track and trend APS activities to ensure regulatory compliance and adherence to Global Quality Standards.

Additional Responsibilities

• Apply sterility assurance risk management principles to evaluate manufacturing processes and controls related to microbial, endotoxin, and particulate contamination risks.
• Analyze microbiological and manufacturing data to identify trends, discrepancies, and improvement opportunities.
• Provide technical support for root cause investigations associated with sterility assurance programs.
• Participate in internal and external audits as a sterility assurance subject matter expert.
• Create, execute, review, and approve technical documents and change controls related to sterility assurance programs.
• Collaborate with cross-functional teams to deliver TSMS objectives and quality goals.

Basic Qualifications

• Bachelor’s or Master’s degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or a related scientific discipline.
• Demonstrated understanding of scientific principles related to sterile pharmaceutical manufacturing including:
• Microbiology

• Environmental Monitoring
• Sterility Assurance
• Validation
• Technical Services
• Quality Assurance within cGMP pharmaceutical manufacturing
• Senior level: 2+ years of pharmaceutical manufacturing experience (Microbiology, TSMS, Sterility Assurance, or related function)
• Principal level: 5+ years of pharmaceutical manufacturing experience (Microbiology, TSMS, Sterility Assurance, or related function)

Additional Skills / Preferences

• Strong interpersonal skills and ability to work cross-functionally within a team environment.
• Strong self-management and organizational skills.
• Strong written and verbal communication skills.
• Experience with data analysis and trending.
• Ability to wear appropriate PPE and work safely in manufacturing, warehouse, or laboratory environments.
• Ability to gown into cleanroom environments as required.

Additional Information

• Monday–Friday schedule.
• Role may initially support project activities and transition into routine manufacturing support as the facility and processes mature.
• Must be flexible to support production schedules, shutdowns, and operational needs.
• Occasional extended hours or off-hour work may be required.
• Tasks may require repetitive motion and standing or walking for extended periods.

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