Sterility Assurance Technical Specialist

Sterility Assurance Technical Specialist

INCOG Bio Pharma Services is seeking someone to join the QC Microbiology team where you’ll play a critical role in maintaining environmental monitoring excellence across their sterile manufacturing operations.

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.

• 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

• 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

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.