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Sterility Assurance Scientist
2 weeks ago
Title: Sterility Assurance Scientist
Location: Concord, NC
Duration: 6 Month Contract (potential of extension)
Responsibilities:
The Sterility Assurance Scientist is a technical role that assists in 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 is a position that develops and implements a
technical agenda and is responsible for providing technical leadership for the Parenteral Process Team. The
principal role is also expected to serve as a mentor within the TSMS team and engage in upstream and external
to site activities related to sterility assurance contamination control strategies are established.
Key Objectives/Deliverables
(Associate/Senior) Ensure and provide oversight and technical guidance for sterility assurance programs
at the manufacturing floor level.
Lead or provide technical oversight for Provide technical support for activities related to sterility
assurance programs including but not limited to:
Airflow Pattern Testing
Environmental Monitoring Performance Qualifications
Aseptic Process Simulations
Cleaning, Sanitization, and Disinfection
Gowning within GMP Classified Areas
Aseptic Processing Techniques
Contamination Control
Assist in the development and implementation of processes and facility monitoring to ensure effective
contamination control strategies are established.
(Senior) Lead or assist in the development and implementation of processes and facility monitoring to
ensure effective contamination control strategies are established.
(Senior) Lead/assist with support and/or provide technical expertise for developing the site's
contamination control strategy and cleaning and sanitization program/strategy, and disinfectant efficacy
strategies.
(Senior) Lead/assist with support and/or provide technical expertise for the facility's cleanroom
gowning and aseptic technique strategy/program.
(Principal) Knowledge in pharmaceutical Microbiology, related to microbiological media,
microbiological enumeration techniques, and microorganism isolation and identification.
(Principal) Lead/provide technical oversight for one or both the Environmental Monitoring (EM) or
Aseptic Process Simulation (APS) program:
(EM) Authoring EM Performance Qualifications (EM PQ) and overseeing the execution.
(EM) Evaluating EM data and authoring EM Trend Reports.
(EM) Assist with identifying facility environmental isolates and how to create and maintain
environmental isolated cultures.
(APS) Authoring APS protocols and overseeing the execution.
(APS) Evaluating the APS data, including personnel qualifications, and authoring APS reports.
(APS) Assist with tracking and tending APS to ensure all regulatory requirements and Global
Quality Standards are met for each manufacturing line/process.
Apply sterility assurance risk management to evaluate manufacturing processes and associated controls
with respect to potential introduction of microbial, endotoxin, and particulate contamination.
Analyze microbial and manufacturing data to identify trends, process discrepancies, and opportunities
for continuous improvements. Lead or provide technical support for root cause investigations associated with sterility assurance
programs.
Participate and/or provide technical sterility assurance support during internal and external audits.
Create, execute, review, and/or approve technical documents and change controls related to sterility
assurance programs.
Work within cross-functional teams to implement TS/MS objective and deliver on business and quality
objectives.
Basic Qualifications:
Bachelor's or master's degree in microbiology, Biology, Biochemistry, Biochemical Engineering,
Chemical Engineering, or other related scientific discipline.
Demonstrated understanding and relevant experience of scientific principles required for manufacturing
parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance,
validation, technical services, and/or quality assurance associated cGMP pharmaceutical manufacturing.
(Senior) 2+ years in pharmaceutical manufacturing (Microbiology, TSMS, Sterility Assurance, or
related dept).
(Principal) 5+ years in pharmaceutical manufacturing (Microbiology, TSMS, Sterility Assurance, or
related dept).
Additional Skills/Preferences:
Possess strong interpersonal skills to work cross-functionally within a team.
Possess strong self-management and organizational skills.
Possess strong oral and written communication skills for communicating to colleagues, management,
and other departments.
Experience with data analysis and trending.
Ability to wear appropriate PPE and other safety related equipment or considerations in manufacturing
warehouse, or laboratory areas.
Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.
Additional Information:
Role is Monday through Friday based and will be phased from a project support role to a routine support
role as the development facility and processes progress. Must be flexible in providing support to
accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hours and / or
off-hour work may be required.
Tasks may require repetitive motion and standing or walking for long periods of time.
Travel may be required during the project phase for training and implementation of sterility assurance
programs.
This job description is intended to provide a general overview of the job requirements at the time it was
prepared.
The job requirements of any position may change over time and may include additional responsibilities not
specifically described in the job description. For GMP purposes, the job description should be updated for
significant changes. As always, you should consult with your supervisor regarding your actual job
responsibilities and any related duties that may be required for the position.
