Cqv Facilities

Vor 5 Tagen

Stein, Schweiz EPM Scientific Vollzeit

We have a current opportunity for a CQV Engineer on a contract basis. The position will be based in Basel or Kanton Wallis. For further information about this position please apply.

The Commissioning Qualification Validation engineer carries out a variety of tasks related to the validation of equipment and facilities. The scope of activities includes the coordination on the installation of equipment, drafting the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according cGMP requirements.

**Key Responsibilities**:

- The CQV Engineer will be involved in all validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others
- The validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ)
- Prepare validation documents. Execution of IQ/OQ and PQ for equipment, systems and utilities
- Write reports of completed validation activities. Work to identify efficiencies in the validation program approach
- Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA's
- Writing and/or revising procedures applicable to the Engineering activities
- Support the Engineering group to prepare the validation, re qualification, and maintenance program
- Perform other duties as assigned

**Key Requirements**:

- Bachelor's Degree in Science or Technical field
- Advanced Level Pharma Industry 5-10 years
- Experience in Delta V system is highly desirable
- Fluent in English and German advantageous
- Skills: Excellent technical writing skills and the ability to document all work in a thorough, accurate and timely manner
- Excellent written and oral communication skills and the ability to work inter-departmentally in an effective manner to carry out daily duties
- Excellent organisational and time management skills

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