The scope of activities includes the installation and qualification of equipment, performing the IOQ/PQ and documenting the results according cGMP requirements.
Validation activities in:
- The (re)qualification of equipment, systems and/or utilities within PharmaCell.
- The validation of IT systems and/or the validation of the installed ICT hardware.
In addition the Validation & IT Engineer will support the QE department on IT related service requests. This includes troubleshooting with IT problems; installation of hard/software and ensuring business continuity on all IT topics.
Tasks and results:
- 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, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ PQ).
- A Bachelor’s degree in related field along with 4+ years related industry experience.
- 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, strong problem solving skills and immune to stress.
- Good proficiency in English
- Good knowledge of standard MS-Office