Summary: 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.
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.
- 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.
- Fluent in English, Dutch considered a huge plus.
- Work Experience: Advanced Level 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 in an effective manner to carry out daily duties.
- Excellent organizational and time management skills.
- Contract: 1 year, possibility of extension until end of 2023.
- 40 hours per week
- Location: Geleen
- Start: ASAP
For more info, please contact Isla Littlewood at +31 20 20 44 502 or firstname.lastname@example.org.