Sterility Assurance Scientist

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.