INCOG BioPharma Services
Sterility Assurance Technical Specialist
INCOG BioPharma Services, Fishers, Indiana, us, 46085
Join our QC Microbiology team where you’ll play a critical role in maintaining environmental monitoring excellence across our sterile manufacturing operations. This individual contributor position reports to the QC Microbiology Manager and offers the opportunity to impact product quality and patient safety through rigorous data analysis and regulatory compliance.
As the Sterility Assurance Technical Specialist, you will be responsible for performing comprehensive trending analysis of environmental monitoring data for routine surveillance programs and specialized projects such as EMPQs. You will collaborate with multifunctional teams, support deviation investigations, and ensure all work meets FDA, EMA, and Health Canada requirements while following industry best practices from USP, PDA, and ISPE.
Essential Job Functions
Perform trending analysis of environmental monitoring data for viable and non-viable particulates from routine surveillance and EMPQ programs
Author and maintain Environmental Monitoring Performance Qualification (EMPQ) reports in compliance with regulatory requirements
Support environmental monitoring deviation investigations with data analysis and trending insights
Participate in multifunctional project teams to support facility qualifications, investigations, and continuous improvement initiatives
Ensure all trending activities comply with FDA, EMA, and Health Canada regulations, as well as USP, PDA, and ISPE guidance documents
Identify trends, patterns, and outliers in environmental monitoring data and communicate findings to stakeholders
Maintain accurate documentation and records in accordance with GMP requirements
Special Job Requirements
Bachelor’s degree in Microbiology, Biology, Chemistry, or related scientific discipline, or equivalent experience
Minimum 2-3 years of experience in pharmaceutical microbiology, quality control, or related GMP environment
Working knowledge of FDA, EMA, and Health Canada regulatory requirements for environmental monitoring
Proficiency in data analysis tools (e.g., Excel, statistical software) and trending methodologies
Strong technical writing skills with attention to detail and accuracy
Ability to work independently and collaboratively in a fast‑paced environment
Additional Preferences
Experience with sterile manufacturing environments and aseptic processes
Familiarity with industry guidance documents for environmental monitoring
Knowledge of statistical process control and data visualization techniques Additional Info about INCOG BioPharma Services At INCOG BioPharma we have built a world‑class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long‑term value for our customers, we are committed to a service‑culture mindset, technical excellence, and a collaborative and team‑centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke‑free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
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As the Sterility Assurance Technical Specialist, you will be responsible for performing comprehensive trending analysis of environmental monitoring data for routine surveillance programs and specialized projects such as EMPQs. You will collaborate with multifunctional teams, support deviation investigations, and ensure all work meets FDA, EMA, and Health Canada requirements while following industry best practices from USP, PDA, and ISPE.
Essential Job Functions
Perform trending analysis of environmental monitoring data for viable and non-viable particulates from routine surveillance and EMPQ programs
Author and maintain Environmental Monitoring Performance Qualification (EMPQ) reports in compliance with regulatory requirements
Support environmental monitoring deviation investigations with data analysis and trending insights
Participate in multifunctional project teams to support facility qualifications, investigations, and continuous improvement initiatives
Ensure all trending activities comply with FDA, EMA, and Health Canada regulations, as well as USP, PDA, and ISPE guidance documents
Identify trends, patterns, and outliers in environmental monitoring data and communicate findings to stakeholders
Maintain accurate documentation and records in accordance with GMP requirements
Special Job Requirements
Bachelor’s degree in Microbiology, Biology, Chemistry, or related scientific discipline, or equivalent experience
Minimum 2-3 years of experience in pharmaceutical microbiology, quality control, or related GMP environment
Working knowledge of FDA, EMA, and Health Canada regulatory requirements for environmental monitoring
Proficiency in data analysis tools (e.g., Excel, statistical software) and trending methodologies
Strong technical writing skills with attention to detail and accuracy
Ability to work independently and collaboratively in a fast‑paced environment
Additional Preferences
Experience with sterile manufacturing environments and aseptic processes
Familiarity with industry guidance documents for environmental monitoring
Knowledge of statistical process control and data visualization techniques Additional Info about INCOG BioPharma Services At INCOG BioPharma we have built a world‑class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long‑term value for our customers, we are committed to a service‑culture mindset, technical excellence, and a collaborative and team‑centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke‑free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
By submitting your resume and details, you are declaring that the information is correct and accurate.
#J-18808-Ljbffr