Specialist II, QC Microbiology

The Role:

ElevateBio is looking for a Quality Control Microbiology Specialist II to join our growing team in Pittsburgh. This role supports assay development and lifecycle activities for the QC Microbiology group, including characterization, optimization, transfer, qualification, verification, validation, and investigation support. The role provides technical support for environmental monitoring, release, stability, and in-process testing, and supports microbiology method development. This position helps train staff, supports laboratory and cleanroom start-up and qualification, and helps ensure sterility assurance and contamination control strategies meet current industry and regulatory expectations. The role works cross-functionally with Quality Assurance and Manufacturing to support production through safety testing, environmental monitoring, and investigations.

Here’s What You’ll Do:

• Ensure consistent execution of microbiological method transfer, qualification, verification, and validation activities supporting internal and client programs.


• Drive improvements to microbiological methods, techniques, equipment, instruments, and testing capabilities, including cleanroom environmental monitoring, personnel monitoring, and facility and utility monitoring.


• Collaborate with Analytical Development on new and rapid microbiological test methods.


• Support product specifications, process control strategies, environmental alert, and action limits.


• Serve as a key subject matter expert for contamination control and sterility assurance programs.


• Interpret microbial identifications and provide impact assessments to support investigations.


• Participate in risk assessments related to aseptic processing and microbiological environmental controls.


• Participate in technical troubleshooting and investigations.


• Review Analytical Development reports, test methods, and process qualification reports for technical accuracy and regulatory alignment.


• Develop, deliver, and coach theoretical, technical, and aseptic training for analysts, operators, and technicians.


• Assist with generating, reviewing, and approving protocols, reports, and CoAs.


• Prepare, evaluate, and present data to cross-functional teams.

Requirements:

• MS in Microbiology is preferred with six or more years of relevant experience.


• Strong communication, interpersonal, and organizational skills.


• Ability to work with others to resolve complex technical and scientific problems.


• Advanced technical knowledge; able to solve complex issues independently.


• Demonstrated experience with GMP-compliant laboratory documentation.


• Experience performing laboratory and/or manufacturing investigations.


• Experience with GxP requirements in biopharmaceutical manufacturing and testing.


• Experience with aseptic processing and cleanroom operations aligned with ISO 14644.


• Experience with compendial safety testing (e.g., bioburden, mycoplasma, endotoxin, and sterility), including rapid methods (e.g., BacT or similar, Milliflex, PCR, and NGS).


• Experience in statistical analysis and visual data presentation is desirable.


• Experience in cell therapy manufacturing or human cell, tissue, and cellular and tissue-based products is desirable.


• Familiarity with medical microbiology, clinical microbiology, or microbiology in a healthcare setting is desirable.