Mivado GlobalPerformance Inc. is a leading provider of industrial solutions, regulatory compliance, and process optimization for the life sciences, biopharmaceutical, cannabis, and advanced manufacturing sectors. We specialize in bridging the gap between operational excellence (Lean Six Sigma, AI-driven automation) and rigorous GxP regulatory compliance.

Role Overview
We are seeking an experienced Process Validation Consultant to join our consulting team. In this role, you will lead and execute end-to-end process validation strategies for client manufacturing operations. Leveraging risk-based methodologies (Validation by Design / Quality by Design) and standard regulations (FDA, Health Canada, EMA), you will ensure our clients’ manufacturing processes are robust, compliant, and optimized for maximum yield and quality.

Key Responsibilities

* Author, review, and execute Process Validation Master Plans (PVMP), Stage 1 (Process Design), Stage 2 (Process Qualification / PPQ), and Stage 3 (Continued Process Verification / CPV) documentation.

* Develop protocols and execution reports for critical process parameters (CPPs) and critical quality attributes (CQAs).

* Coordinate cleanroom, utility, and equipment integration into validation workflows alongside Commissioning & Qualification (C&Q;) teams.

2. Quality Risk Management & Compliance

* Lead risk assessments (FMEA, PHA) following ICH Q9 and Quality by Design (QbD) principles.

* Ensure strict adherence to GxP, Health Canada, US FDA, and ISO 9001:2015 frameworks.

* Support non-conformance, deviation investigations, and root cause analysis (RCA),



generating actionable CAPAs for validation deviations.

3. Cross-Functional Consulting & Tech Transfer

* Support technology transfer programs between R&D;, clinical scaling, and commercial manufacturing sites.

* Apply Lean Six Sigma methodologies to eliminate process variability and optimize cycle times during validation phases.

* Interface directly with client project managers, engineering teams, and quality assurance executives to communicate validation milestones.

Required Qualifications

* Education : Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Biotechnology, or a related scientific discipline.

* Experience : 3+ years of hands‑on process validation experience in a GxP regulated industry (Pharmaceuticals, Biopharmaceuticals, Medical Devices, or Cannabis GPP/GMP).

* Regulatory Knowledge : Deep understanding of 21 CFR Part 11/210/211, Annex 15, Health Canada GUI-0029/0069, and ICH Guidelines (Q8, Q9, Q10, Q11).

* Technical Proficiency : Experience with statistical analysis tools (Minitab, JMP) for process capability ($C_p, C_{pk}) and CPV monitoring.

* Languages : Bilingual Imperative (French language capabilities are a strong asset for Quebec‑based operations).

Preferred Qualifications

* Experience with Microsoft SharePoint, automated systems, AI‑driven process controls, ERP or LIMS integrations.

* Familiarity with cleaning validation, transport validation, or environmental control strategies.

Job Features
Job Category Contract, Internship, Temporary

Additional Information We are an equal prospect employer.

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📌 Specialist, Process Validation (Quebec City)
🏢 Mivado GlobalPerformance
📍 Quebec City