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Curia Microbiologist I in Burlington, Massachusetts

Microbiologist I in Burlington, MA

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Microbiologist I is an integral part of the Curia team, contributing to our success by performing quality activities in support of product production and releases. The Microbiologist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending and reporting results.

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Essential Duties and Responsibilities

  • Perform microbiological testing (endotoxin, bioburden) for water

  • Perform microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product

  • Perform environmental monitoring of the clean rooms (under USP and EU specifications)

  • Read, trend and report environmental, personnel, in-process, raw material, finished product and water testing results

  • Perform microbial characterization (gram stain, catalase, oxidase, and coagulase tests)

  • Prepare and send out samples for microbiological identification

  • Maintain historical files on organisms found in classified areas; microbial identification and trending

  • Perform line clear and line start verifications

  • Inspect media fills

  • Perform other microbiological assays:

  • Preservative Effectiveness testing

  • Microbial Limits testing

  • QC microbiological sample receipt for internal testing, login, processing, tracking, distribution of test results, and closure

  • Provide support of general QC Microbiology Laboratory activities such as:

  • Chart reading and changing

  • Equipment cleaning and maintenance

  • Maintaining supplies and inventory

  • General laboratory housekeeping

Education and Experience Required

  • Bachelor’s degree in a scientific discipline; microbiology strongly preferred

  • Previous experience with pharmaceutical cleanroom environments

  • Preferred

  • 1-3 years’ industry experience in a GMP or GLP environment

  • Knowledge, Skills and Abilities

  • Proficient in the validation/qualification of lab microbiological techniques preferred

  • Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 a plus

  • Strong organizational skills and the ability to prioritize/multitask

  • Proficient in Microsoft Office Suite (excel)

  • U.S. employees of Curia Global Inc. and its subsidiaries (a “Company”) must be fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of their employment except for U.S. employees who request and qualify under applicable law for disability and religious accommodations from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S. employee will be required to provide proof of vaccination, or to request and receive a disability or religious accommodation that the applicant is entitled to under applicable law, before their first day of employment or any earlier or later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regards to an individual’s disability or religion or on any other basis prohibited by applicable law.

Physical Demands

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.

Work Environment

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.

All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.