Qualification Lead – Laboratory Instrumentation (Validation Specialist)

Position Type: 3-6 months contract (extendable)

Location: On-site, Kildare, Ireland

Start Date: Immediate

Experience Level: 3–5 Years (Qualification and Validation Focus)

Role Overview:

We are seeking an experienced and proactive Qualification Lead to manage and execute the qualification activities of a range of laboratory instruments. The role demands a hands-on approach, full-time site presence, and the ability to work collaboratively with laboratory, quality, and engineering teams.

This opportunity will suit an individual who is confident writing protocols, executing qualification activities, and producing detailed reports. You will work directly on a portfolio of critical laboratory instruments, supporting operations readiness and regulatory compliance.

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Key Responsibilities:

• Prepare, write, and review qualification protocols (IQ, OQ, PQ as applicable) for laboratory equipment.
• Execute qualification protocols in a hands-on laboratory setting.
• Complete and compile qualification reports ensuring traceability and data integrity.

Manage qualification activities for the following equipment types:

• Media Delivery Systems
• Vacuum Ovens
• LCMS Systems
• Karl Fischer Titrators
• Brookfield Viscometers
• Water Baths and Circulators
• Polarimeters
• Autotitrators
• Oil Bath and Viscotemp units
• Micro Balances
• FTIR Instruments

• Collaborate with laboratory, engineering, quality assurance, and external vendors to facilitate seamless execution.
• Maintain accurate, timely documentation aligned with cGMP standards.
• Support equipment troubleshooting and liaise with vendors where necessary.
• Ensure all qualification work meets regulatory expectations and internal policies.

Requirements:

• Bachelor’s degree in Science, Engineering, or a related technical field (or equivalent work experience).
• 3–5 years’ hands-on experience in equipment qualification within a GMP or regulated laboratory environment.
• Demonstrated experience writing and executing qualification protocols independently.
• Familiarity with regulatory requirements for laboratory equipment (e.g., EU GMP Annex 15, FDA regulations).
• Strong attention to detail, organisational skills, and time management abilities.
• Effective communication skills for interaction with cross-functional teams.
• Comfortable with full-time, on-site working arrangements.
• Immediate availability preferred.

Desirable Skills:

• Experience with mass spectrometry and chromatography systems.
• Knowledge of data integrity principles (ALCOA+).
• Previous experience within biopharmaceutical, pharmaceutical, or medical device industries.