Validation Operations Engineer

Hobson Prior are currently looking for an Validation Operations Engineer to join a world-wide biopharma organisation focused on improving the lives of patients globally through pioneering medicines. This role will be on a contract basis in Switzerland.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• May be assigned Subject Matter Expert role for a defined validation/qualification.
• Develop and justify 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.
• Review change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions.
• 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.
• Participate 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.
• Establish and maintain effective relationships with internal team, customers and suppliers.
• Contributes to continuous improvement, including proactively identifying problems and proposing solutions.
• Autonomous; completes work independently, seeking guidance on complex tasks and on non- routine decisions.
• Participates in projects and initiatives as directed by their leader.

Key Skills:

• Communicates pro-actively and collaboratively.
• Team player: ability to interact effectively with team and customers.
• Languages French and English.

Requirements:

• BS/MS in Engineering/Technical discipline or equivalent experience.
• 5 years experience in pharmaceutical Validation or related field.
• Familiarity with current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP.
• Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems.
• Automation knowledge advantageous.

Apply now:

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.