Curia

Microbiologist II

Position overview

The Microbiologist II performs activities in support of product production and releases. The Microbiologist III performs a wide variety of activities such as conducting testing, trending and reporting results.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

We proudly offer

• Generous benefit options
• Paid training, vacation and holidays
• Career advancement opportunities
• Education reimbursement
• 401k program
• And more!

Supervisory responsibilities

This position does not have supervisory responsibilities.

Essential job duties

1. Perform microbiological testing (endotoxin, bioburden) for water
2. Perform microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product
3. Perform environmental monitoring of the cleanrooms (under USP and EU specifications)
4. Read, trend and report environmental, personnel, in-process, raw material, finished product and water bioburden testing results
5. Perform microbial characterization (gram stain, catalase, oxidase and coagulase tests)
6. Prepare and send out samples for microbiological identification
7. Maintain historical files on organisms found in classified areas; microbial identification and trending
8. Inspect media fills
9. Perform other microbiological assays:
   1. Preservative Effectiveness testing
   2. Microbial Limits testing
   3. Sterility testing (including Biological Indicator testing)
   4. Growth promotion testing of all incoming media used in the microbiology laboratory
   5. Cytotoxicity/Biological Reactivity
   6. Other tests as trained and assigned
10. Microbiological sample receipt for internal testing, login, processing, tracking, distribution of test results, and closure
11. Provide support of general Microbiology Laboratory activities, such as:
    1. Chart reading and changing
    2. Equipment cleaning and maintenance
    3. Maintaining supplies and inventory
    4. General laboratory housekeeping
12. Lead microbiology investigations, propose appropriate CAPA(s) and assure that CAPAs are completed properly and on-time
13. Prepare formal laboratory documentation including, microbiology test methods, SOPs, procedural guidelines, and microbiology related sections of regulatory submissions, annual reports, and PQRs
14. Facilitate the revision and release of all controlled documents, mandatory reviews of SOPs and month end reports
15. Provide oversight for projects to update/maintain official document templates
16. Direct and manage the Change Control System

Education, experience, certification and licensures

Bachelor’s degree in Microbiology or related field

Minimum 3-5 year’s industry experience in a GMP or GLP environment

Knowledge, skills and abilities

1. Strong organizational skills and ability to prioritize and multi-task in a fast-paced environment
2. Strong knowledge of validation/qualification of lab microbiological techniques
3. Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 a plus
4. Excellent verbal and written communication skills, including the ability to proficiently lead business meetings and work related social and business development situations
5. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals and communicate this information to others
6. Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
7. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
8. Ability to define problems, collect data, establish facts, and draw valid conclusions
9. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
10. Knowledge of manufacturing, spreadsheet and word processing software

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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 regularly required to stand; walk; reach with hands and arms. The employee is occasionally required to 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

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. 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. Curia is an E-Verify employer.

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