Validation Engineer (C&Q)

• Tasks:
o Is responsible to create and follow up the required change notifications/CRF.
o Is resposible for defining and executing the engineering tests, verification and validation of assigned equipment. Defines the validation approach, creates test protocols for engineering tests, creates verification and validation documents, executes tests, coördinates SME and system owner approvals. Is responsible to solve and document deviations and actions (CAPA’s, risk assessments, CGMP review, new document versions).
o Supports other validations (ECO, SMC, batch records) executed by other departments.
o As responsible for the CRF, the PE will support the registration process in relation with site compliance if required.
o Supports documentation of technical specs (Engineering Design Specification or technical spec, P&ID’s, electrical diagrams) and reviews with the relevant PE/SME.
• Profile:
o Good documentation skills, able to deliver clear and complete documents
o Good communication skills
o Pragmatic, pro-active, can take the lead
o Results focussed
o Able to work independently but is also a teamplayer
o Experienced in planning and project coordination (MS Project is a plus)
o Quality minded – experience in pharma (GMP, risk assessments, verification & validation)
o Hands-on and good problem solving skills
o Shows ownership

• Specific vacant roles:
o 1 Equipment Qualification Engineer with experience in C&Q of automatic inspection equipment for semi-finished product (particles, cosmetic defects, fill volume, leak testing) – needed as soon as possible
o 2 Equipment Qualification Engineers with experience in moving and requalification of inspection (or packaging) equipment – needed by summer 2018
o 1 Equipment Qualification Engineer with experience in C&Q of Freeze Dry equipment – availability throughout 2019 summer period is a must – needed beginning 2019
o 1 Equipment Qualification Engineer with experience in C&Q of ALUS systems (automatic loading & unloading of freeze dryers) – availability throughout 2019 summer period is a must – needed beginning 2019
o Potential candidates with C&Q experience of preparation equipment (autoclaves, washers, …) or other equipment will also be reviewed
• General: Language is subordinate to experience, but fluent English (read and write) is a minimum