Laboratory/Validation Instrumentation Specialist-Part Time
Location: On-site, Kildare, Ireland
Position Type: 3–6 month contract
Start Date: Immediate
Experience Level: 3–5 Years (Qualification and Validation Focus)
Role Overview:
We are seeking a Qualification Lead to oversee the qualification activities of laboratory instrumentation at a regulated site in Kildare. This role involves managing the end-to-end qualification process, coordinating with vendors, tracking timelines, and reporting progress to stakeholders. The position requires strong planning and organisational skills, with the ability to manage multiple systems simultaneously in a dynamic environment.
This is a on-site contract role ideal for someone with a solid understanding of equipment qualification within GMP settings and experience leading cross-functional projects.
Key Responsibilities:
* Oversee the timely qualification of laboratory instrumentation in line with project schedules and regulatory standards.
* Coordinate with vendors to align on timelines and service requirements for qualification activities.
* Liaise with laboratory, engineering, and quality teams to ensure readiness and compliance.
* Maintain oversight of qualification documentation (protocols and reports) to ensure completeness and traceability.
* Provide regular updates to stakeholders, highlighting progress, potential delays, and mitigation plans.
* Manage qualification planning and scheduling using tools such as Microsoft Project.
* Ensure all qualification activities align with cGMP and internal quality policies.
Laboratory Equipment in Scope:
* 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
Requirements:
* Bachelor’s degree in Science, Engineering, or a related field (or equivalent work experience).
* 3–5 years of experience in equipment qualification or validation in GMP or regulated environments.
* Strong knowledge of regulatory requirements (EU GMP Annex 15, FDA) for laboratory instrumentation.
* Proven ability to coordinate qualification activities and manage vendor relationships.
* Excellent documentation and communication skills.
* Experience with Microsoft Project or similar project management tools.
* Comfortable with on-site presence.
* Immediate availability preferred.
Desirable Skills:
* Familiarity with mass spectrometry and chromatography systems.
* Experience in pharmaceutical, biopharmaceutical, or medical device industries.
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