Senior Specialist, Quality Control (Microbiology)

Job Description
The Microbiology QC Senior Specialist is a key technical leadership role providing high-level oversight of the QC Microbiology programs and quality systems. The role focus is on leading complex microbiology investigations, coordinating cleanroom qualification and Environmental Monitoring/Utilities program strategies, executing advanced technical reviews and driving technological innovation (e.g., rapid micro methods). The role ensures compliance with sterile manufacturing standards (such as Annex 1), coordinates regulatory audit responses and supports method qualification and technology transfers.
Bring energy, knowledge, innovation to carry out the following:
Technical Oversight of Programs:
Provide advanced technical oversight of the Environmental Monitoring (EM) and clean utilities (WFI, gases, clean steam) programs, ensuring alignment with current global regulatory expectations (such as EU Annex 1).
Technical & Peer Record Review:
Perform critical technical review and secondary verification of complex laboratory records, validation data packages, method transfer protocols and high-impact testing records (e.g., sterility and endotoxin assays) to guarantee complete compliance.
Microbiology Investigations & CAPA:
Author, review and facilitate high-level, complex microbiological investigations (including sterility failures, adverse bioburden trends and systemic EM excursions)
Ensure robust Root Cause Analysis (RCA) is executed and effective CAPAs are implemented
Risk Management:
Participate in contamination control risk assessments (e.g., FMEA, HACCP) to support cleanroom qualifications, VHP cycles and routine environmental monitoring site selection
Validation & Tech Transfer:
Oversee the qualification of microbiological methods (Bioburden, Endotoxin, and Sterility testing) and advanced QC Micro laboratory equipment (e.g., autoclaves, and isolators)
Regulatory Representation:
Act as a technical spokesperson for QC Microbiology during regulatory inspections (e.g., HPRA, FDA) and lead the preparation of inspection-readiness within the QC microbiology laboratory
Continuous Improvement:
Champion the implementation of new technology and digital innovation in the microbiology lab
Documentation Leadership:
Author and pre-approve complex technical documents and validation protocols
What skills you will need:
In order to excel in this role, you will more than likely have:
B.Sc. or M.Sc. degree in Microbiology, Biological Sciences or equivalent
5-7 years of pharmaceutical/biotechnology industry laboratory experience, with a proven track record in technical leadership
Demonstrated expertise in leading root cause investigations for environmental excursions, sterility failures or OOS microbiological results
Extensive experience with cleanroom qualification and cleanroom start-up activities
Expert knowledge of CFR, Eudralex (specifically Annex 1), FDA/EMA guidance and international compendial requirements for sterile products
Advanced technical writing skills with a focus on investigation reports and risk assessments
Strong leadership, project management and decision-making capabilities to lead cross-functional problem-solving teams
Strong verbal and written communication skills, with the ability to summarise complex microbiological trends for site executive leadership
Experience with Lean Six-sigma tools to optimise lab workflows and sample turnaround times
Excellent interpersonal and communication skills to influence internal site stakeholders and global partners
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
Required Skills:
Analytical Thinking, Bioburden Testing, Biological Indicators, Clean Rooms, Endotoxin Testing, Environmental Monitoring, Inspection Readiness, Microbiology, Quality Risk Assessment, Root Cause Analysis (RCA), Sterility Testing, Troubleshooting
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
10/24/2026
*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.