Engineer/Specialist, computer system validation (CSV).

Brief description of the position :

In order to meet the needs of its clients in the (Bio)pharmaceutical sector, FOP CONSULTANTS is looking for computerized systems validation consultants motivated to carry out mandates. The main missions would be to manage computerized systems validation projects, define the validation strategy, perform risk analyzes and coordinate commissioning until project closure, write and execute protocols (IQ, OQ, PQ), write standard operating procedures (SOPs) and reports related to the validation of computerized systems.

Main responsibilities :

Without limitation, the main tasks involve:

• Manage the implementation of VSI projects from conception to project closure;
• Develop the computerized systems validation strategy (CSV);
• Carry out a risk analysis of the inventory and define the IS validation methods;
• Write protocols (IQ, OQ, PQ) and CSV reports;
• Write Standard Operating Procedures (SOPs) related to CSV;
• Coordinate or participate in the execution of tests in collaboration with related services (maintenance, quality assurance, production, etc.);
• Perform periodic reviews of CSV activities and ensure compliance with quality assurance procedures (PON) internally at the client;
• Write down, if necessary, the deviations encountered and follow up to implement the CAPAs.
• Audit in order to identify shortcomings and put in place remediation plans.
• Provide solutions to problems encountered and perform all tasks relevant to the mandate;

Qualifications :

• Bachelor's or Master's degree in engineering (computer science, software, automation, industrial, chemical, mechanical), computer science, pharmaceutical sciences or any other related discipline;
• 1 (one) to 10 (ten) years of industry experience, preferably in the (bio)pharmaceutical, food or cosmetics, ICT sector;
• Project management (an asset);
• Demonstrated experience in Computerized Systems Validation (CSV);
• Knowledge of GAMP 5, 21 CFR part 11 and Data integrity;
• Knowledge of regulations (Health Canada, FDA);
• Excellent skills in MS Office Suite.
• Good communication and writing skills in French and English;
• Mobility (an asset).

Personal skills :

• Leadership;
• Rigor et discipline;
• (Organize), able to manage several projects;
• Analytical and critical mindset;
• Perseverance;
• Humility.

What we offer :

In order to allow the full development of our team members, FOP CONSULTANTS guarantee the support and comfort necessary for the achievement of their mandate. The main advantages offered are as follows:

• Competitive wages;
• Group insurance;
• Professional insurance;
• Remote work, according to the customer needs;
• Vacations: 3 weeks;
• Paid sick leave: 3 days;
• Monthly transportation fees;
• Career advancement opportunity;
• Continuing education.