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Laboratory Specialist

Independent Solutions

Leinster

On-site

EUR 45,000 - 70,000

Full time

15 days ago

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Job summary

An established industry player is looking for a proactive Qualification Lead to oversee the qualification activities of laboratory instruments. This role requires a hands-on approach and full-time presence on-site in Kildare, Ireland. You will be responsible for writing and executing qualification protocols, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. If you have a strong background in equipment qualification and are ready to contribute to critical laboratory operations, this is an exciting opportunity to make a significant impact in a dynamic environment.

Qualifications

  • 3-5 years of hands-on experience in equipment qualification within a GMP environment.
  • Demonstrated ability to write and execute qualification protocols independently.

Responsibilities

  • Prepare and execute qualification protocols for laboratory equipment.
  • Compile qualification reports ensuring traceability and data integrity.

Skills

Qualification Protocol Writing
Equipment Qualification
Regulatory Compliance
Attention to Detail
Effective Communication

Education

Bachelor's Degree in Science or Engineering

Tools

LCMS Systems
Vacuum Ovens
Karl Fischer Titrators
Brookfield Viscometers
Micro Balances

Job description

Qualification LeadLaboratory 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)

Attractive Pay Rate

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.
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