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Engineer Validation Operations

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Engineer Validation Operations
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!

Responsibilities
  • 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

Profile
  • 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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Please apply directly online by clicking on "Apply Now".

About Us
Advance your career, find a job that you love or discover a new opportunity for professional growth – we believe in these goals and work every day to help you achieve them. Spring Professional is a subsidiary of The Adecco Group specialising in temporary and permanent placement of qualified professionals.
Find out what we can do for you. Apply for this job, or for one of over 500 other vacancies at SpringProfessional.ch

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