Job Description: Senior QC Instrumentation Specialist
Location: Ireland (Hybrid / On-site options available)
Industry: Biopharmaceuticals / Life Sciences
Role Type: Permanent, Full-Time
Position Overview
A leading multinational biopharmaceutical company is seeking a Senior QC Instrumentation Specialist to join their Quality Control Shared Services team. Reporting directly to the QC Instrumentation Lead, the successful candidate will oversee the complete lifecycle management of laboratory equipment-including procurement, installation, calibration, and qualification-to support routine biopharmaceutical drug substance and drug product operations.
Key Responsibilities
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Lifecycle & Maintenance Management: Lead the scheduling, execution, and oversight of laboratory instrument calibrations, routine maintenance, and overall asset lifecycle tracking.
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Qualification & Documentation: Review and approve documentation for equipment qualification, calibration, and repair activities, ensuring all verification procedures align with operational intent.
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Investigative Oversight: Drive technical investigations related to instrument performance, including calibration deviations and troubleshooting complex analytical equipment.
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Cross-Functional Collaboration: Partner with QC, QA Validation, and Computer System Validation (CSV) teams to execute qualifications for new equipment.
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Vendor & Network Liaison: Coordinate with external vendors and global site networks regarding equipment purchasing, technical support, and lifecycle updates.
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Compliance & Governance: Ensure all instrumentation activities comply with corporate policies, global regulatory standards, and data integrity guidelines (21 CFR Part 11 / EU Annex 11).
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Continuous Improvement: Establish and refine lab instrument procedures while tracking performance trends across analytical systems.
Qualifications & Experience
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Education: B.Sc. (or higher) in a relevant scientific discipline (Biochemistry, Chemistry, Biotechnology, or equivalent).
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Experience: Minimum 3 years of experience in a GMP laboratory setting, with at least 1 year directly focused on laboratory instrument qualification.
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Technical Expertise: Hands-on experience with key biopharmaceutical analytical platforms, such as:
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HPLC / UPLC
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Capillary Electrophoresis (CE / cIEF)
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SDS-PAGE
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Surface Plasmon Resonance (Biacore)
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Particle Counting (HIAC)
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Karl Fischer (KF) Titration
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Automated Liquid Handlers
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Regulatory Knowledge: Solid understanding of Data Integrity principles (21 CFR Part 11 and EU Annex 11) within a regulated GMP environment.
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Desirable: Knowledge of protein biochemistry and prior experience with technology transfers.
Key Competencies
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Strong organizational and project management capabilities, with the ability to manage competing priorities across multiple projects.
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Excellent interpersonal and communication skills.
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Proven ability to collaborate effectively within cross-functional, team-based environments.
