specialists in serialization (Int.)

FOP CONSULTANTS is looking for specialists in serialization at the intermediate level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to deploy and maintain serialization and aggregation solutions compliant with DSCSA, EU FMD and GS1 requirements and to integrate packaging, MES and ERP systems, validate the solutions and support operations

• Analyze market serialization and traceability requirements (DSCSA, EU FMD).
• Design and deploy serialization solutions on packaging lines (levels 1 through 5).
• Configure aggregation, 2D codes (GS1 DataMatrix) and data exchange (EPCIS).
• Coordinate integration with ERP, MES and traceability platforms.
• Draft and execute validation protocols for serialization systems.
• Diagnose and resolve production and data exchange incidents.
• Train users and document operating procedures

• Bachelor's or master's degree in engineering (computer science, software, automation, industrial, chemical, mechanical) or any other related discipline.
• Five (05) to ten (10) years of industry experience.
• Three (03) to seven (07) years of experience as a Specialist in Serialization.
• Sector standards: GMP (Health Canada), FDA 21 CFR 210-211, ICH Q7 to Q10, GAMP 5, ISO 9001.
• Tools and systems: MS Office suite, TraceLink, SAP ATTP, Systech, MS Project.
• Hold one of the following certifications: GS1, GAMP 5, PMP.
• The following are considered assets: ASQ CQE, Six Sigma Green Belt.
• Experience in Canadian public or private organizations.
• Language: French and English

• Remote, Hybrid, On-site

At FOP CONSULTANTS, we invest in the success and well-being of our experts. By joining our team, you benefit from an environment designed to support your performance and respect your work-life balance, including:

• Competitive compensation that reflects your expertise;
• Complete protection through our group insurance plans;
• Professional liability insurance so you can practise with confidence;
• Remote-work flexibility, based on client needs;
• 3 weeks of vacation to recharge;
• 3 paid sick days, to take care of yourself;
• A monthly allowance for your transportation costs;
• Real opportunities for advancement within the organization;
• Ongoing access to training to grow your skills.