Analyst II, QC Microbiology

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Responsibilities:

• Performs Environmental Monitoring (EM) of Controlled Classified Areas

• Performs compendial assays such as Bioburden Test, media Growth Promotion Test, Sterility Tests and Biological Indicators (BI) analysis

• Perform method suitability tests

• Utilities Monitoring (UM) and Testing for Bioburden and Bacterial Endotoxin

• Performs Microbial Isolations and Identification Tests

• Supplies inventory and lab organization

• In-process and finished product samples to include bioburden, bacterial endotoxin, and sterility.

• Raw material testing for specific microbial requirements.

• Routinely gown and maintain certifications for all classified/controlled manufacturing areas. Keep and maintain cGMP certification.

• Environmental Monitoring of cleanrooms and dynamic processes including viable air sampling, surface sampling, non-viable air sampling, and personnel monitoring.

• Sampling and analysis of purified water, Water for injection and clean steam.

• Sampling and analysis of compressed gases and air.

• Biological indicator receipt, issuance, and analysis.

• Media fill inspection

• Growth promotion of media and media fill units.

• Perform microbial identifications, evaluating and interpreting results to identify objectionable organisms from environmental monitoring and product testing.

• Demonstrate the ability to understand and interpret test results and use the results to decide with regard to acceptance of the associated criteria and requirements.

• Conduct laboratory deviation investigations developing CAPA's for non-conformances/excursions

• Perform data entry and understanding of trend reports

• May perform role of Administrator for lab-based software.

• Identifying and purchasing the necessary supplies needed to support laboratory needs.

• Training other employees on tasks where the Analyst 1 is an SME or trainer.

• Other duties as assigned.

Minimum Qualifications:

• Experience in GMP Laboratory operations, ideally doing Environmental Monitoring (EM) for Viable and Non-Viable Particulate and Utilities Monitoring (UM) and testing and/or any other Microbiological Testing.

• Working knowledge of cGXP requirements and a strong familiarity with production operations.

• Good problem-solving skills

• Proficient in math, laboratory and computer skills. Understand basic statistics and microbiology terminology.

Preferred Qualifications:

• Bachelor's degree in Microbiology, Science, biology or related field

• Laboratory experience in Pharmaceutical industry

• Working knowledge of laboratory equipment, operations, and safety.

Role/Site Specific Requirements

This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exertion up to 20 pounds of force to move objects.

Visual acuity such as: working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.

Participation in an occupational health program (which can include medical assessment, surveillance, vaccination, and testing)

Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.)

Exposure to the following:

• Handling, managing, disposing hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.), inclusive of exposure to bloodborne pathogens

• Working in BSL-2/3 laboratories & production rooms, waste holding areas, or other facilities where biological hazards and hazardous chemicals may be stored or handled.

• Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.

• Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.