Microbiology (MicroSeq) Specialist Quality Control

Job Description

Microbiology (MicroSeq) Specialist Quality Control

Microbiology QC Specialist — MicroSEQ / Microbial ID (New Micro Lab, Sterile Manufacturing Site)

We are establishing a new microbial identification lab at our high-throughput sterile manufacturing site and seek a skilled Microbiology QC Specialist to lead MicroSEQ-based microbial identification and microbial laboratory set-up. This is a hands-on, individual-contributor role that offers visible impact: validate and implement microbial identification workflows, manage the end-to-end identification workflow, including sample preparation, DNA extraction, PCR amplification, sequencing, and data interpretation. Maintain and troubleshoot MicroSEQ instrumentation, software, and reagent inventory to ensure uninterrupted testing capacity. This role is ideal for an experienced lab scientist who wants to be part of a new laboratory build, deliver measurable quality improvements, and grow technically and professionally.

Core skills we are seeking

• Laboratory setup: design, equip, qualify and maintain a compliant micro lab; write IQ/OQ/PQ and validation protocols.
• Microbial identification: hands-on MicroSEQ or equivalent sequencing
• DNA extractions: reproducible isolation from environmental and water-system isolates.
• PCR amplification: setup, optimization and troubleshooting for ID workflows.
• DNA sequencing: prepare, run and interpret sequencing (MicroSEQ or similar).
• GMP / cGMP & ALCOA(+): QC lab experience with controlled documentation and electronic systems.

Key Responsibilities

• Lead MicroSEQ lab setup, equipment/reagent selection, and method validations.
• Validate and run MicroSEQ workflows: sample prep, DNA extraction, PCR, sequencing and data interpretation.
• Perform routine/nonroutine microbial IDs for environmental, water and investigation samples under cGMP.
• Maintain/troubleshoot instruments, software and inventory; qualify suppliers as needed.
• Review and approve sequencing data; ensure traceability and ALCOA(+) integrity.
• Support audits/inspections, training, deviations, CAPAs, change controls and regulatory submissions.
• Act as SME: mentor colleagues, lead transfers/projects, and collaborate with Manufacturing/QA/Utilities.
• Approve QC SOPs and report quality metrics; drive continuous improvement to reduce microbial excursions.

Qualifications

• Bachelor’s degree or higher in Microbiology, Molecular Biology or related field (advanced degree preferred).
• Hands-on experience with MicroSEQ or equivalent sequencing platforms.
• Proven DNA extraction, PCR and sequencing workflow experience.
• Strong aseptic processing, environmental monitoring and contamination-control background in sterile manufacturing.
• Experience in a cGMP QC lab; familiarity with ALCOA(+), LIMS/ELN and controlled documentation.
• Strong troubleshooting, documentation and communication skills; ability to work independently and train others.
• Willingness to work shift patterns aligned with site operations as required.

Why join us

• Lead and shape a new micro lab with high visibility and impact.
• Be technical owner of MicroSEQ-based ID capability and contamination-control strategy.
• Clear path for technical growth, SME roles and leadership opportunities.

Our facility in Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges

Required Skills:

cGMP Compliance, DNA Extractions, DNA Sequencing, GMP Laboratory, Laboratory Setup, Microbial Identification, PCR Amplification

Preferred Skills:

cGMP Regulations, People Management

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

NA

Job Posting End Date:

04/27/2026

*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.