CQV Engineer (m/f/d) (Ref.Nr. LA3165)
Brine
- Wallis
- Unbefristet
- Vollzeit
- Coordination of the installation of equipment,
- Drafting the IQ/OQ/PQ protocols,
- Execution of the IQ/OQ/PQ
- Documenting the results according cGMP requirements.
- The CQV Engineer will be involved in all validation activities : Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.
- 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.
- Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validation.
- 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, requalification, and maintenance program.
- Bachelor's Degree in Science or Technical field.
- minimum 3 years' experience in advanced level Pharma Industry.
- 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 in an effective manner to carry out daily duties.
- Excellent organizational and time management skills.
- English Mandatory and German is a plus.