Seize the freedom to define your future by joining Philip Morris. We are currently looking for an Instrument Validation Engineer
The Instrument Validation Engineer is primarily responsible for validating laboratory instruments and software. The incumbent ensures that laboratory instruments are validated as per internal (PMI QMS) and international requirement (ISO:2017 and GLP); prepare, review and approve the related documentation; and provide support during audits.
Accountabilities
1. Validation documents: Provide validation expertise for the validation of computerized systems. This includes the development of validation plans and reports, as well as the development or review of various documents such as: User Requirements and Systems Specifications, - IQ/OQ/PQ/UAT test scripts and reports, Traceability matrices, SOPs/WKIs/User Guides and Deviations.
2. User Acceptance Tests (UAT): Execute UATs or guide laboratory personnel in their execution to ensure the system meets user needs and requirements.
3. Liaison with IT and QA: Serve as the primary point of contact with IT and Quality Assurance (QA) for the implementation and validation of computerized systems.
4. Manage instruments periodic review.
Education
* Bachelor in Science or Quality
* Ideally Master in Science or Quality
Work experience
* At least 3 years of experience in computerized systems validation, quality and instrument qualification in the Life Sciences industry.
Other skills
* Good Knowledge of Computerized Systems Validation (e.g. GAMP 5, CFR 21 part 11)
* Knowledge of ISOand OECD Good Laboratory Practices is preferred
* Excellent planning and organizational skills
* Fluent communication and written skills in English
* Stakeholder management
* Knowledge of IT is preferred
We offer A long-term temporary assignment within an international scientific environment.
The opportunity to play a key role in a strategic laboratory systems improvement project .
? Interested?
Apply now and be part of a motivated, collaborative, and forward-thinking team at Philip Morris International .
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