Your Challange:

Analyze projects in order to create the Validation Master Plan (listing of all qualification activities that are needed to finalize the project);

Make risk analysis for all systems and components of an industrial project: HVAC, Clean Utilities, Piping, Process (and process control):
CLIA;SLIA.

Settle the validation strategy of the project to optimize the results (leveraging);

Write validation protocols for each step of the validation phase:
IQ;OQ;PQ.

Help the project team and/or the client to be prepared for the validation;

Write/update checklist;

Write/update SOP;

Participate to preliminary testing;

Execute validation protocols: witness execution, control results and attest in a report to submit to the client’s QA department;

Finalize the project with Validation Summary Report.

Your Qualifications and Experience:

Education: Master (chemistry, biochemistry, microbiology, pharmacy, civil engineer interested in the pharma industry), industrial engineer with significant experience in the pharmaceutical biotechnology industry;

Skills: Good knowledge of MS Office Word/Excel/Access/PowerPoint. Knowledge of SAP is an asset;

Languages: English/French/Dutch very good, knowledge of other languages is an asset;

Experience: at least 5 years;

Driver license B;

In addition to your sense of organization and method, you are rigorous in your work;

You are proactive;

Ability to participate effectively in team-based information sharing environment;

Ability to plan, prioritize and deliver tasks on time;

High client service orientation and initiative to solve problem, excellent analytical and communication skills;

Consistently approaches work with energy and positive, constructive attitude;

Ability to work with minimum supervision;

Affinity with technical issues;

Ability to lead a validation team on a project.

Validation Engineer

Validation Engineer