Title: Senior Validation Engineer
Contract Duration: 12 Months
Location: County Carlow, Ireland
Are you looking for a way to make a real impact? As a Senior Validation Engineer, you will play a key role in ensuring compliance within a cGMP-regulated environment, with a focus on Cleaning Validation, including Recovery and Cleanability studies.
This is a great opportunity for an experienced validation professional with a background in pharmaceutical or biopharmaceutical manufacturing, looking to apply their expertise in a fast-paced, high-performance environment.
Key Responsibilities
* Develop, review, and execute qualification and validation protocols, including:
Cycle Development (CD), Performance Qualification (PQ), mobile vessels and part washers.
* Design, author, review, approve, and execute validation documentation and change controls.
* Identify and resolve technical issues encountered during validation activities.
* Drive compliance with cGMP, FDA, and ISO regulations, supporting audits and regulatory submissions.
* Represent the validation team in cross-functional projects and global technical discussions.
Requirements
* Experience in cleaning validation, including recipe development and optimisation, cleanability/recovery studies, and cleaning verification using TOC, ICP, and swab methods.
* Strong knowledge of validation within a pharmaceutical manufacturing environment.
* Hands-on experience with Deviation Management, Change Control, and process monitoring systems.
* Relevant technical qualification in Applied Pharmaceutical, Biological, or Chemical Sciences, or Engineering.
* Ability to analyse complex data, link findings to equipment performance, and identify out-of-specification results.
* Excellent written and verbal communication skills to effectively collaborate with internal teams and external regulatory bodies.
Preferred Experience (Advantageous but Not Required)
* Filter Validation, CCI Qualification, Shipping Qualification
* Sterilisation Validation (Autoclave/SIP, Dry Heat, Isolator VHP/HVAC Qualification)
* Equipment Periodic Validation & Lifecycle Management
If you are looking for an opportunity to contribute your expertise in a high-impact role, apply today.
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