Scientist, Analytical R&D
- Perform routine viable and non-viable Environmental Monitoring of classified cleanroom areas (Grad A-D), including surfaces, air, and equipment.
- Conduct active air, passive air (settle plates), surface sampling, in accordance with site EM programs and GMP requirements.
- Operate and maintain EM instruments (e.g., viable air samplers, particle counters, RODAC plates, isolator/BSC environmental sampling tools).
- Execute aseptic sampling techniques to ensure data integrity and contamination-free sample collection.
- Perform utility sampling/testing (WFI, purified water, clean steam) and support routine water system monitoring.
- Perform microbiology laboratory testing associated with EM samples, including bioburden, microbial identification, and endotoxin testing.
- Trend, analyze, and interpret EM data; escalate atypical or out-of-trend (OOT) results and support investigations.
- Participate in deviation investigations, root cause assessments, and CAPA development related to environmental or microbiological events.
- Maintain accurate documentation of sampling activities in compliance with ALCOA and data-integrity principles. Inventory management.
- Conduct microbiology finished goods testing and biological indicator (BIs) testing
- Support of sterile operations within the quality control department including-utilizing isolator for-sterility testing, conduct method suitability testing, endotoxin, microbial enumeration, media / reagent quality control testing, Experience with testing in clean room environments preferred
- Conduct the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA and data integrity principles
- Partner with internal stakeholders and partners, including Quality, Pipeline, and Operations.
- Perform second scientist review microbiology experiments in line with GMP expectations
- Support internal and external compliance audit activities.
- Conduct other job duties as per management assignments/business requirement.
- Be flexible weekday work hours and weekend support as needed
- Minimum 2 years of pharmaceutical industry experience for applicants with a MS degree or
- 3 years of experiences for BS degree in Microbiology or related Biological Sciences, or equivalent with direct microbiological testing GMP experience.
- A proven record of microbiology laboratory experience. Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role.
- Knowledge and experience of microbiology testing in context of, environmental monitoring, aseptic manufacturing, and utilities testing in a GMP environment
- Knowledge of current microbiology industry guidelines and compendia
- Knowledge in sterile, nonsterile and aseptic manufacturing and associated GMP product testing
- Experience in supporting quality investigations in the microbiology discipline
- Experience with MODA, SAP, Veeva, LIMS is a plus.
Analytical Method Development, Biological Sciences, Environmental Monitoring, Good Manufacturing Practices (GMP), Laboratory Techniques, Laboratory Testing, Microbiological Test, Microbiology Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement• We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is
$87,300.00 - $137,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits.- Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at . You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.- Employee Status:
Regular Relocation:
No relocation VISA Sponsorship:
No Travel Requirements:
10% Flexible Work Arrangements:
Not Applicable Shift:
2nd - Evening Valid Driving License:
No Hazardous Material(s):
N/A Job Posting End Date:
07/17/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R407613
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