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 set‑up: 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 extraction: reproducible isolation from environmental and water‑system isolates.
PCR amplification: set‑up, optimization and troubleshooting for ID workflows.
DNA sequencing: prepare, run and interpret sequencing (MicroSEQ or similar).
GMP / cGMP & ALCOA(+) compliance: QC lab experience with controlled documentation and electronic systems.
Key Responsibilities
Lead MicroSEQ lab set‑up, equipment/reagent selection, and method validations.
Validate and run MicroSEQ workflows: sample prep, DNA extraction, PCR, sequencing and data interpretation.
Perform routine/non‑routine 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 is a cutting‑edge production site for vaccines, biologics and small‑molecule drug products, featuring state‑of‑the‑art laboratories and strong collaboration with local universities.
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