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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.

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Position Summary:

The Sterility Assurance Lead is accountable for assisting in the development and oversight of the implementation of the microbial contamination control and viral safety programs at Resilience.

This is an exciting opportunity to contribute to the establishment of a robust and comprehensive contamination control program. The Sterility Assurance Lead will collaborate with multiple stakeholders to ensure the harmonized execution of contamination control policies across the Resilience network.

This role will also support new product transfers related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods.

The Sterility Assurance Lead is a key support role and reports to the Site Quality Head - Alachua.

The position will be an onsite position in Alachua, FL. Relocation assistance can be available.

Position Responsibilities:

• Championing sterility assurance principals at the site and serving as the microbial control site technical leader in the areas of aseptic processing, contamination control and viral safety.

• Support the site compliance to the global microbial/viral control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, cleanroom management, microbiological methods and validations including RMM, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments

• Ensure alignment and harmonization regarding global microbiological/aseptic standards and compendial/regulatory requirements

• Responsible for establishing and maintaining the site Contamination Control Strategy (CCS) and management of the gap assessments and risk assessments related to Annex 1 and CCS compliance

• Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial/viral controls

• Lead site microbial and cross contamination LOPA and HACCP risk assessments

• Participate in site Contamination Control Review Committee (CCRC) meetings as the Sterility Assurance SME

• Act as compliance and innovation subject matter expert during the selection and qualification of laboratory equipment for microbiological and viral safety testing including Rapid Microbial Methods (RMMs), ensuring alignment with the global micro strategy

• Support site QC in microbiology deviations, LIR, OOS, Change controls and CAPA records

• Support inspection readiness plans and interact with regulatory agencies during inspections on Microbial Contamination Control and Viral Safety program related matters

• Provide microbial SME support for microbial investigations and microbiological/aseptic related challenges to the Resilience network

• Lead efforts, in collaboration with other site and company experts, to ensure compliance and adequate cleanroom design, airflows, traffic flows, cleaning and disinfection, aseptic gowning, aseptic techniques and behaviors.

• Actively participate in industry forums such as PDA, ISPE, BPOG, etc. to lead external engagement and benchmark industry trends and standards

Minimum Qualifications:

• Significant experience in a microbial contamination control role within the pharmaceutical or biotechnology industry

• Knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology

• Strong knowledge of microbiological and sterility testing (i.e. environmental monitoring, clean room qualification and management, quality control endotoxin testing and microbiological control strategy)

• Experience with oversight of aseptic processing and the associated international aseptic processing regulations

• Experience with microbiological risk assessments

• Knowledge and familiarity with Annex 1

• Comprehensive knowledge of global GMP regulatory requirements for biologics

• Excellent oral and written communication skills with strong technical writing experience required

• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders

• Ability to synthesize data and summarize outcomes to provide recommendations on a compliant path forward

Preferred Qualifications:

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field

• Background in Microbiology

• Risk Assessment facilitation

• Contamination Control strategy experience

• Experience in tech transfer

Role/Site Specific Requirements:

This position may also include the following:

• This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.

• Visual acuity such as working with data & figures, viewing computer terminal, extensive reading, operating machinery, 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:

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

• 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.

• Packaging, transporting, and shipping of infectious or potentially infectious substances

The items described here are representative of those that must be met to successfully perform the essential functions of this job.

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.