Urgent! We are recruiting, on behalf of our client, en experienced Validation Engineer with experience in the pharmaceutical industry. You have experience in equipment qualification, process and systems validation in the pharmaceutical industry? We have the right opportunity for you!
May be assigned Subject Matter Expert role for a defined validation/qualification area.
Develop and justify the validation approach based on risk and scientific rationale
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 equipments 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
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
Communicates pro-actively and collaboratively
Team player: ability to interact effectively with team and customers
Good level of English
Ability to communicate in French is preferred
Contact Spring Professional Life Science: + 41 58 233 40 20
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