ProClinical is currently seeking a Process Validation Engineer for a global healthcare company operating in more than 100 countries, committed to effective corporate governance, adherence to the law, and a culture of ethics and compliance throughout the organisation. This role is a contract role based in the United Kingdom.
- Equipment / Facility Qualification
- Knowledge of EU GMP Annex 15.
- Authoring User Requirement Specifications for systems validation as standalone documents or to form part of an overall document for a process or set of equipment.
- Capable of devising, developing and authoring, along with execution, of Design / Installation / Operational / Performance Qualification protocols and reports for systems validation
- Review and assessment of third party supplier Design Specifications against User Requirement Specifications.
- Capable of devising, developing and authoring, along with execution, of Design / Installation / Operational / Performance Qualification protocols and reports for systems validation.
- Capable of preparing and presenting validation report packages to line management
- Knowledge of the requirements for pharmaceutical grade utilities e.g. WFI, PW, clean steam, compressed air.
- Capable of taking samples from these systems.
- Capable of reading P&IDs (and welding documentation).
- Capable of conducting IQ/OQs on small to medium modifications to existing systems.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Ivan Gitardi on +44 203 0789 551 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.