Our client is active in the food, life sciences, infrastructure, oil and gas and (petro) chemical markets by delivering:
- Support through consulting & engineering;
- delivering turnkey automated solutions;
- maintenance and support.
- Prepare validation documents
- Execute IQ/OQ and PQ for equipment, systems and utilities.
- Document preparation and execution of ICT validations
- Write reports of completed validation activities
- The Validation Engineer will be involved in all validation activities in the Validation Life Cycle of Facilities, Utilities, and Equipment. This would include the execution, technical documentation, GAP Analysis and Risk Assessment.
- The validation documentation deliverables include URS, DQ, FMEA, RiskAssessments, FAT, SAT, Protocols (IQ, IOQ, OQ PQ).
- A Bachelor’s degree in related field
- Two to four years of experience required in the medical device, biotechnology or pharmaceutical industry.
- Sound knowledge of GMP, laboratory and pharmaceutical validation principles including FDA and EMA expectations in the field of computer systems validation.
- Excellent communication skills in both Dutch and English (oral and technical written).
- Flexible, innovative, customer-oriented, pro-active, hands on and immune to stress.
- Good proficiency in English
- Good knowledge of standard MS-Office