Company Description

MIVADO GlobalPerformance (MIVADO GP) is a global value-added consulting and training firm serving public and private organizations across multiple industries. The company offers expertise in areas such as Artificial Intelligence, Data Transformation, Digital Quality Management, Lean Six Sigma, Continuous Improvement, Validation, GMP Compliance, and Manufacturing Process Optimization. Positioned at the forefront of the life sciences marketplace, MIVADO GP is recognized for quality services, tailored training programs, and strong customer support.

Through strategic partnerships, the firm delivers integrated performance solutions where optimization, validation, quality, and innovation are closely aligned to client needs. Candidates can expect to join a team committed to high standards, continuous learning, and impactful consulting engagements.

Role Description The Consultant, Process Validation is responsible for planning, executing, and documenting validation activities to ensure that manufacturing and computerized systems meet regulatory and quality requirements. Working in a contract capacity, this role focuses on developing validation master plans, protocols, and reports, and collaborating with cross-functional teams to assess process risks, define controls, and implement improvements.

The consultant will review and interpret technical data, support audits and inspections, and provide guidance on best practices in validation, data integrity, and GMP compliance. This is a hybrid role based in the Greater Quebec City Metropolitan Area, with a combination of in office client work and some work-from-home flexibility. The position calls for a structured, analytical professional who can manage multiple projects, communicate clearly with stakeholders, and contribute to continuous improvement initiatives.

Qualifications





- Strong expertise in Validation and Process Validation, with proven experience executing and documenting validation activities.
- Proficiency in Computer System Validation and Computerized System Validation (CSV) for manufacturing and quality-related systems.
- Solid foundation in Quality Assurance practices, including risk management, deviation handling, and change control.
- In-depth knowledge of Good Manufacturing Practice (GMP) and applicable regulatory guidelines in life sciences or related industries.
- Bachelor’s degree in engineering, life sciences, pharmacy, or a related technical field; advanced degree or professional certifications (e.g., Lean Six Sigma, CSV, QA) are an asset.
- Experience in the life sciences, pharmaceutical, biotechnology, or medical device sectors, with familiarity in data integrity and digital quality management.
- Strong analytical, problem-solving, and documentation skills, with attention to detail and ability to meet project deadlines.
- Effective interpersonal and communication skills, with the ability to collaborate in hybrid work settings and client environments.

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 (Cp/Pp; Cpk/Ppk) and CPV monitoring.
- Languages: Bilingual Imperative (French language capabilities are a strong asset for Quebec-based operations).

📌 Consultant, Process Validation (Quebec City Metropolitan Area)
🏢 Mivado GlobalPerformance
📍 Quebec City Metropolitan Area