Capilaux
Validation Engineer
Job Location
Woolverton, United Kingdom
Job Description
Job Title: Validation Engineer
Location: UK
Employment Type: Full time, Permanent or Contractor
About the Role:
We are seeking a highly skilled and detail-oriented Validation Engineer. This role focuses on testing, qualifying, and validating equipment used in regulated environments such as pharmaceuticals, biotechnology, or food storage. The ideal candidate will ensure all equipment operates reliably within specified parameters, meeting regulatory and quality standards.
Due to a number of exciting projects and a trusted presence across the UK, we are looking to talk to people who are seeking full time and contract employment.
Key Responsibilities:
* Plan, execute, and document validation protocols (IQ, OQ, PQ) for temperature-controlled equipment, including refrigerators, freezers, and cold storage units. Knowledge and experience with autocalves would be a bonus.
* Conduct performance testing, mapping, and calibration of equipment to ensure compliance with industry standards (e.g., GMP, GDP, ISO 17025).
* Collaborate with cross-functional teams, including engineering, quality assurance, and operations, to develop validation strategies and address non-conformance issues.
* Analyse data from temperature mapping and validation studies, generating detailed reports with actionable insights.
* Maintain up-to-date knowledge of regulatory requirements, ensuring all validation activities align with FDA, EMA, and other relevant guidelines.
* Troubleshoot technical issues on-site and recommend corrective and preventive actions.
* Provide training to operational staff on proper use and maintenance of validated equipment.
* Ensure all documentation is accurate, complete, and audit-ready.
Qualifications:
* 2+ years proven experience in equipment validation within regulated industries such as pharmaceuticals, biotech, or medical devices.
* Strong understanding of temperature mapping, thermal validation principles, and data logging equipment.
* Familiarity with regulatory standards (e.g., GMP, GDP, ISO 13485, FDA 21 CFR Part 11).
* Proficiency with validation tools and software.
* Excellent analytical, organizational, and problem-solving skills.
* Strong communication skills, with the ability to work independently and in a team environment.
* Willingness to travel to client sites for validation activities.
Preferred Skills:
* Experience with thermal qualification software and sensors (e.g., Kaye, Ellab, MadgeTech).
* Knowledge of quality systems (e.g. Change Management, CAPA)
* Experience with testing autoclaves.
Why Join Us?
* Opportunity to work on cutting-edge equipment in a dynamic and regulated environment.
* Comprehensive training and development programs.
* Competitive compensation and benefits package which includes 25 days annual leave + bank holidays, pension, car allowance.
Please note, you must have the right to work. We are unable to provide sponsorship
Location: Woolverton, GB
Posted Date: 12/26/2024
Location: UK
Employment Type: Full time, Permanent or Contractor
About the Role:
We are seeking a highly skilled and detail-oriented Validation Engineer. This role focuses on testing, qualifying, and validating equipment used in regulated environments such as pharmaceuticals, biotechnology, or food storage. The ideal candidate will ensure all equipment operates reliably within specified parameters, meeting regulatory and quality standards.
Due to a number of exciting projects and a trusted presence across the UK, we are looking to talk to people who are seeking full time and contract employment.
Key Responsibilities:
* Plan, execute, and document validation protocols (IQ, OQ, PQ) for temperature-controlled equipment, including refrigerators, freezers, and cold storage units. Knowledge and experience with autocalves would be a bonus.
* Conduct performance testing, mapping, and calibration of equipment to ensure compliance with industry standards (e.g., GMP, GDP, ISO 17025).
* Collaborate with cross-functional teams, including engineering, quality assurance, and operations, to develop validation strategies and address non-conformance issues.
* Analyse data from temperature mapping and validation studies, generating detailed reports with actionable insights.
* Maintain up-to-date knowledge of regulatory requirements, ensuring all validation activities align with FDA, EMA, and other relevant guidelines.
* Troubleshoot technical issues on-site and recommend corrective and preventive actions.
* Provide training to operational staff on proper use and maintenance of validated equipment.
* Ensure all documentation is accurate, complete, and audit-ready.
Qualifications:
* 2+ years proven experience in equipment validation within regulated industries such as pharmaceuticals, biotech, or medical devices.
* Strong understanding of temperature mapping, thermal validation principles, and data logging equipment.
* Familiarity with regulatory standards (e.g., GMP, GDP, ISO 13485, FDA 21 CFR Part 11).
* Proficiency with validation tools and software.
* Excellent analytical, organizational, and problem-solving skills.
* Strong communication skills, with the ability to work independently and in a team environment.
* Willingness to travel to client sites for validation activities.
Preferred Skills:
* Experience with thermal qualification software and sensors (e.g., Kaye, Ellab, MadgeTech).
* Knowledge of quality systems (e.g. Change Management, CAPA)
* Experience with testing autoclaves.
Why Join Us?
* Opportunity to work on cutting-edge equipment in a dynamic and regulated environment.
* Comprehensive training and development programs.
* Competitive compensation and benefits package which includes 25 days annual leave + bank holidays, pension, car allowance.
Please note, you must have the right to work. We are unable to provide sponsorship
Location: Woolverton, GB
Posted Date: 12/26/2024
Contact Information
| Contact | Human Resources Capilaux |
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