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INCOG BioPharma Services · 2 days ago

Sterility Assurance Technical Specialist

Fishers, IN

Full-time

Onsite

Entry, Mid Level

2+ years exp

INCOG BioPharma Services is a world-class CDMO for parenteral injectable drugs, focused on building long-term value for customers. The Sterility Assurance Technical Specialist will be responsible for maintaining environmental monitoring excellence and ensuring compliance with regulatory requirements to impact product quality and patient safety.

BiopharmaBiotechnologyManufacturingPharmaceutical

Responsibilities

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

Qualification

Environmental monitoringData analysisRegulatory complianceStatistical softwareGMP environmentTechnical writingAseptic processesCollaborationAttention to detail

Required

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

Preferred

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

Company

INCOG BioPharma Services

Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.

Founded in 2020

Fishers, Indiana, USA

201-500 employees