Laboratory Validation Specialist - Capital Projects

Every new laboratory instrument has to be bought, installed, qualified and proven before a scientist can rely on its results. In this role, you're the person who makes that happen.

A leading pharmaceutical company in Co. Tipperary is growing its laboratory capability, and that growth has created a new position. They need a Laboratory Validation Specialist to own the installation, qualification, lab CSV and decommissioning of analytical instruments across its development and commercial laboratories.

This is an ideal next step for a QC or Analytical Chemist who has become the go-to person for instruments in their lab, handling installs, qualifications and system setup. It's equally suited to a Validation or Lab CSV Engineer looking to own complete projects, or a Laboratory Instrument Specialist ready to take on more responsibility. Many validation roles give you one piece of the process. This one gives you the whole lifecycle, from purchase order to validated release.

You'll own the projects that keep the laboratories equipped, compliant and running:

• Lead the installation and decommissioning of laboratory instruments, keeping laboratory downtime to a minimum
• Order new laboratory equipment, with documentation that meets System Development Life Cycle (SDLC) requirements
• Author the validation master plans, protocols and final reports that define how each instrument is proven fit for use
• Execute equipment qualification studies, covering installation, operational and performance qualification (IQ/OQ/PQ)
• Carry out computer system validation (CSV) on software-controlled instruments
• Analyse validation data, and review and approve validation activities
• Release instruments in a validated state and set them up for ongoing maintenance and periodic verification
• Troubleshoot technical issues during installation, and take investigations through to close-out
• Bring in and coordinate vendor service engineers on site
• Update SOPs and supporting documentation
• Act as auditee for your area, standing behind your work during audits and inspections
• Shape departmental initiatives on compliance and quality systems

• A degree in analytical chemistry, pharmaceutical science, engineering or a related scientific discipline, or equivalent experience
• Experience in equipment validation or qualification within a GMP environment
• Hands-on experience with analytical instruments such as HPLC/UPLC, GC, dissolution or spectroscopy
• Lab CSV experience, including GAMP 5, 21 CFR Part 11 and EU Annex 11
• Experience with chromatography data systems such as Empower, LIMS, or equipment asset management systems
• Knowledge of Data Integrity and ALCOA+ principles
• Experience with deviations, investigations, and supporting audits or regulatory inspections
• Strong technical writing skills, including protocols, reports and SOPs
• Strong planning, time-management, communication and problem-solving skills
• The ability to manage multiple installs at once and work with moderate direction, both independently and within a team

Equivalent experience will be considered in place of a formal qualification.

It's a newly created role. You're joining because the laboratories are investing in new capability, so you'll arrive with real projects in front of you and visible work from day one.

It gives you end-to-end ownership. You'll take instruments from purchase order to validated release, and your name will be on the protocols, reports and approvals that prove the work. That's strong, CV-building experience in laboratory validation, lab CSV and capital project delivery.

It brings breadth across a laboratory portfolio covering drug substance and drug product in both clinical and commercial areas. You'll also work alongside laboratory teams, quality and specialist instrument vendors.

All applications are treated in strict confidence.