Validation Engineer Operations
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Hobson Prior are currently working with a world-wide biopharma organisation focused on improving the lives of patients globally through pioneering medicines. Our client is seeking a Validation Engineer Operations on a contract basis in Switzerland
- To review change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions.
- May be assigned Subject Matter Expert role for a defined validation/qualification area.
- Continuously developing and justifying the validation approach based on risk and scientific rational.
- Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
- Author and when required review validation documents, including requirement specifications, validation plans, protocols, reports, traceability matrix and summary reports.
- Execute qualifications for all equipment and systems across the site, including QC, production, warehouse, facilities, equipment, utilities and computer system validation, excluding global IT systems.
- Execute validations for all processes across the site, including cleaning processes, bulk process, packaging processes and warehouse / sampling processes.
- Contributes to the development and maintenance of the local site procedures.
- Lead risk assessments and risk management teams.
- Manage validation projects; including managing time, resources and budgets; own associated change controls.
- Co-ordinate qualification and validation execution activities, including external vendors and internal departments.
- Partake when required during internal and external audits for which they are a SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation.
- Communicates pro-actively and collaboratively.
- Ability to interact effectively with team and customers.
- Good level of English.
- Ability to communicate in French is preferred.
- You will need to require a BS/MS in Engineering/Technical discipline or equivalent experience.
- Be familiar with current international regulatory regulations, cGxP requirements and best practices.
- A minimum of 5 years' experience in pharmaceutical Validation or related field.
- Strong knowledge of pharmaceutical facilities, manufacturing, and laboratory systems.
- Automation knowledge will also be an advantage.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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