Engineer/Project Manager, serialization.

Brief description of the position :

In order to meet the needs of our customers in the Pharmaceutical and Biopharmaceutical sectors, FOP CONSULTANTS is looking for serialization project manager consultants motivated to carry out mandates. The main missions would be to manage the serialization projects of systems and processes, coordinate the commissioning until the validation of the serialization projects, write and execute the protocols, write the standard operating procedures (SOPs) and the reports related to the serialization.

Main responsibilities :

Without limitation, the main tasks involve:

• Manage the implementation of serialization projects from conception to project closure;
• Perform a risk analysis of the inventory and define the serialization methods;
• Make a technology watch by evaluating the serialization solutions offered on the market;
• Coordinate or participate in the execution of commissioning activities until validation (FAT, SAT, IQ, OQ, PQ) of the serialization project;
• Write serialization protocols and reports;
• Participate in the implementation of the SNMS (Serial Number Serialization System) system architecture;
• Participate in the creation of serialization models for the coding and maintenance of systems and process data;
• Perform periodic reviews of serialization activities and ensure compliance with quality assurance procedures (SOP) internally at the customer;
• Write up, if necessary, the deviations encountered and follow up to implement the CAPAs;
• 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) or any other related discipline;
• 1 (one) to 10 (ten) years of experience in industry, preferably in the (bio)pharmaceutical, food or cosmetics sector;
• Project management (an asset);
• Demonstrated experience in serialization projects in industry;
• Experience in Computerized Systems Validation (CSV), an asset;
• Knowledge of programming languages and database administration (an asset);
• Knowledge of regulations (Health Canada, FDA, EMA);
• 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.