Sterility Assurance Scientist

Job Description

Title : Sterility Assurance Scientist – Night Shift

Location : Concord, NC

Duration : 12-Month Contract

Shift: 12-hour nights, 2-2-3 rotation (3 shifts one week, 4 the next)

ABOUT THE ROLE

Our client is seeking a Sterility Assurance Scientist for a 12-month contract to support parenteral pharmaceutical manufacturing operations on night shifts in the Charlotte area, NC. This highly hands-on, manufacturing-floor-focused role is responsible for developing and implementing site sterility assurance programs, providing technical guidance in environmental monitoring, contamination control, aseptic process simulations, airflow pattern testing, gowning and aseptic techniques, isolator glove management, and cleaning/sanitization strategies. The Sterility Assurance Scientist will work closely with Operations, Quality Assurance, and Environmental Monitoring teams, serving as an embedded resource during aseptic production activities and addressing sterility and product quality-related questions. The position requires strong technical troubleshooting, investigation, and cross-functional collaboration skills, as well as the ability to mentor and train staff while ensuring compliance with safety and quality standards. The role operates on a 2-2-3 rotating 12-hour night shift schedule (three shifts one week, four shifts the next), with initial training on day shift, and may require flexibility for production needs, shutdowns, and occasional extended or off-hour work.

WHAT YOU'LL DO

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• Serve as an embedded resource and extension of the Sterility Assurance Process Team, providing hands-on technical guidance to operators and manufacturing personnel during production.
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• Spend the majority of each shift coaching, auditing, and communicating within aseptic processing areas to reinforce proper aseptic practices and identify/report events affecting aseptic conditions.
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• Correct improper aseptic techniques and communicate observations and corrective actions to manufacturing supervisors.
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• Troubleshoot manufacturing process issues, respond to unplanned events requiring aseptic interventions, and lead/coordinate remediation activities such as recovery cleaning and alarm responses.
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• Recognize issues requiring escalation and engage appropriate technical, quality, engineering, or leadership resources.
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• Ensure compliance with site safety requirements and actively participate in safety-related activities.
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• Lead or support deviation investigations resulting from manufacturing-floor events, including sterility assurance investigations and associated technical studies.
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• Perform root cause analysis and develop, execute, and monitor the effectiveness of corrective and preventive actions (CAPAs).
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• Collaborate with Quality Assurance, Operations, and TS/MS teams to assess sterility, product quality, and manufacturing process impacts.
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• Gather, organize, and analyze manufacturing, environmental monitoring, and microbiological data to support investigations and identify process trends, discrepancies, and opportunities for improvement.
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• Provide technical oversight and guidance for site sterility assurance programs, including airflow pattern testing (smoke studies), bioburden requalification studies, environmental monitoring performance qualifications (EMPQ), aseptic process simulations (APS/media fills), cleaning/sanitization/disinfection, GMP gowning, aseptic interventions, barrier glove management, and contamination control strategies.
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• Support Environmental Monitoring program activities, including performance qualification execution, deviation investigations, data evaluation, and EM trend reporting.
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• Support Aseptic Process Simulation activities, including protocol execution, personnel qualification data evaluation, and report preparation.
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• Execute or assist with qualification and validation activities, including Performance Validation (PV) protocols, airflow pattern testing, bioburden qualifications, and manufacturing process studies.
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• Provide technical support for maintaining bioburden control of manufacturing facilities and equipment.
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• Partner with Manufacturing, Quality Assurance, Operations, Maintenance, Environmental Monitoring, Engineering, and other technical teams to support sterility assurance objectives.
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• Serve as a technical subject matter resource for aseptic operations, bioburden control, sterility assurance, and product quality questions.
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• Coach, mentor, and train scientists, technicians, and manufacturing operators on aseptic techniques, technical requirements, and troubleshooting.
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• Support training activities associated with smoke studies, qualification activities, and sterility assurance programs.
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• Communicate technical issues, aseptic technique observations, personnel behaviors, and recommendations to technical and operations leadership.
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• Support knowledge transfer, continuous improvement, and implementation of contamination control strategies.
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WHAT YOU BRING

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• Bachelor's degree in Microbiology, Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or another relevant scientific or technical discipline.
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• Demonstrated understanding of scientific principles associated with parenteral pharmaceutical manufacturing, microbiology, environmental monitoring, sterility assurance, validation, technical services, and/or quality assurance within a cGMP manufacturing environment.
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• Experience providing sustained, hands-on technical support for manufacturing processes or product lines during commercial or scale-up production.
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• Direct experience troubleshooting manufacturing issues, investigating deviations, performing root cause analysis, and supporting CAPA development and execution.
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• Experience mentoring or training scientists, technicians, and/or manufacturing operators.
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• Demonstrated ability to collaborate cross-functionally with Manufacturing and Quality teams.
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• Ability to gown into facility-specific cleanroom attire as required.
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• Ability to work 12-hour night shifts on a rotating 2-2-3 schedule (three shifts one week, four shifts the next), with initial training on day shift.
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• 5+ years of relevant pharmaceutical or biopharmaceutical manufacturing experience (preferred).
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• Experience in Sterility Assurance, Technical Services/Manufacturing Sciences (TS/MS), Manufacturing Science and Technology (MSAT/MS&T), Environmental Monitoring, Parenteral Operations, Process Engineering, or a comparable manufacturing technical support function (preferred).
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• Experience supporting formulation, aseptic filling, and/or visual inspection operations (preferred).
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• Experience supporting commercial pharmaceutical production in a 24/7 manufacturing environment (preferred).
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• Experience with GMP documentation, deviation management, and change control systems, including Veeva Vault Quality, TrackWise, or Kneat (preferred).
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• Experience with data analysis and trending systems such as PharmaSuite, MODA, Citrix Global Reports Generator, or PI Vision (preferred).
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• Strong written and verbal communication skills, including the ability to communicate technical information across departments.
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• Flexibility to accommodate production schedules, shutdowns, and operational needs, including occasional extended or off-hour work.
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• Ability to wear appropriate personal protective equipment (PPE) and cleanroom gowning, and perform repetitive motion and prolonged periods of standing or walking as required within manufacturing and laboratory environments.
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