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CSV Engineer - Singapore

Job Title: Computer System Validation Engineer
Duration: Long Term Contract
Salary: TBC
Location: Singapore

My client, a multinational Pharmaceutical Company, is seeking an individual who can carry out COMPUTER SYSTEM VALIDATION.

Job Scope + Requirements:

The qualification includes, FAT, SAT, IQ, OQ, PQ of any additional / modifications of existing Siemens PCS7 automation control hardware and software logics. IQs, OQs and PQ of the PCS7 system functionalities running under the manufacturing processes in full system integration. A great opportunity for those looking to apply their technical skills, and become part of a well-known & established organisation.

•Experience to create: reviews, approve computer system validation lifecycle documentations, e.g. FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
•Experience in coordinate cross functionals (including local and global teams) for the creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents.
•Experience in managing the qualification protocol execution process (cross functional), deviations management, and status reporting
•Proficient in technical write up of validation lifecycle documentation (e.g. validation project plan, validation protocols, validation reports, validation discrepancies)
•Experience in computer system validation in qualifying process control systems.
•Knowledge in recombinant processes under GMP environment
•Knowledge in Process Control Systems, preferred Siemens PCS7 platform
•Knowledge in Enterprise Resource Planning Systems, preferred JD Edwards platform
•Knowledge in Enterprise Manufacturing Intelligence Systems, preferred Aegis Discoverant
•Knowledge in Enterprise Infrastructure Data Management Systems, preferred OSI PI

If you feel that you qualify for this role, please send across your CV to iram.a.a4ljrs7yrer@leap29.aptrack.co.uk
Alternatively if this may not be for you, kindly recommend someone to me + pass this message around. All the best!

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