Overview
Senior Validation Engineer Jobs in Carlow, County Carlow, Ireland at i-Pharm Consulting
Title: Senior Validation Engineer
Company: i-Pharm Consulting
Location: Carlow, County Carlow, Ireland
Title: Senior Validation Engineer
Contract Duration: 12 Months
Location: Netherlands
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) and Performance Qualification (PQ) for mobile vessels (CIP) and parts washers (COP).
Design, author, review, approve, and execute validation documentation and change controls.
Identify and resolve technical issues encountered during validation activities.
Conduct risk assessments, root cause analysis, and deviation investigations.
Collaborate with Production, Maintenance, and Quality teams to ensure validation requirements are met.
Drive compliance with cGMP, FDA, and ISO regulations, supporting audits and regulatory submissions.
Support continuous improvement initiatives through Lean Six Sigma methodologies.
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.
Strong problem-solving and analytical skills with a hands-on approach.
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
Project Management Skills or Qualification
At our company, we work at the forefront of science and technology to drive manufacturing excellence and R&D across our global network. We are committed to making a difference in the lives of patients and communities worldwide.
If you are looking for an opportunity to contribute your expertise in a high-impact role, apply today.
