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

• 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.

Invent solutions to meet unmet healthcare needs 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

Employee Status

Regular

Flexible Work Arrangements

Not Applicable

Job Posting End Date

09/10/2026

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

R414428

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA