CQV Engineer m/w/d, WallisWe are looking for a Commissioning Qualification Validation engineer, who carries out a variety of tasks related to the validation of equipment and facilities within biopharmaceutical manufacturing.
Your responsibilities: - Coordination on the installation of equipment.
- Drafting and execution of IQ/OQ/PQ protocols and documentation of results according cGMP requirements.
- Validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.
- Validation documentation deliverables including URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
- Write reports of completed validation activities.
- 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.
Your background: - Bachelor's Degree in Science or Technical field.
- Fluent German and English language.
- Experience in pharma industry 5-10 years.
- 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 interdepartmentally
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