Senior Validation Engineer

4 weeks ago


The Municipal District of Carlow, Ireland i-Pharm Consulting Full time

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.

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