Senior Sterility Assurance Engineer — GMP Microbiology Lead

Rti Surgical Inc; Eden Prairie (MN); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

PTO

401(k) with company match

Holiday pay

Medical, dental, and vision insurance

Disability coverage

Job summary

Evergen in Eden Prairie, MN is seeking a Senior Sterility Assurance Engineer to lead microbiology and contamination-control efforts in a GMP environment. You will oversee environmental monitoring, aseptic processing, method qualification, and CAPA investigations in collaboration with manufacturing to ensure product quality.

Required: a Bachelor’s in Microbiology or related field (Master’s preferred), 4–6 years in sterile processing, ISO/GMP knowledge, and strong documentation and leadership

Qualifications

• Bachelor’s degree in Microbiology, Biology, or related field required (Master’s preferred).
• Minimum 4–6 years of relevant microbiology/sterility assurance experience in regulated GMP environments.
• Strong hands-on microbiology expertise and lab practices.
• Experience with ISO 13485, ISO 13408, ISO 14644, FDA Aseptic Processing Guidance, EU GMP Annex 1.

Responsibilities

• Serve as site SME for microbiology, sterility assurance, aseptic processing, and contamination control.
• Implement and improve the site Contamination Control Strategy (CCS).
• Oversee environmental monitoring program, trends, and investigation triggers.
• Support microbiological testing, bioburden, endotoxin, sterility, and microbial characterization.
• Review batch records and data to assess compliance and product impact.
• Lead investigations involving microbiological OOS/OOT, EM excursions, and contamination events.
• Train and mentor staff on microbiological techniques and cleanroom practices.
• Author and approve GMP documentation, SOPs, protocols, and risk assessments.
• Assist in regulatory submissions, validations, and product launches.

Skills

Attention to detail

Documentation practices

Analytical skills

Investigation skills

Cross-functional collaboration

Communication

Education

Bachelor’s degree in Microbiology or related field

Master’s degree preferred

Job description

Evergen in Eden Prairie, MN is seeking a Senior Sterility Assurance Engineer to lead microbiology and contamination-control efforts in a GMP environment. You will oversee environmental monitoring, aseptic processing, method qualification, and CAPA investigations in collaboration with manufacturing to ensure product quality.

Required: a Bachelor’s in Microbiology or related field (Master’s preferred), 4–6 years in sterile processing, ISO/GMP knowledge, and strong documentation and leadership