Job Description Summary

As the Senior Quality Engineer, Validation, you will ensure that commissioning, qualification, and validation (CQV) strategies and documentation for equipment, facilities, and processes are accurately captured and addressed. You will support existing manufacturing operations and new product launches, serving as the primary point of contact for CQV-related topics. By identifying and recommending improvements to validation processes, you will help ensure that STEMCELL's manufacturing equipment, processes, and systems are audit- and market-ready.

Job Description

Duties and Responsibilities

• Implement comprehensive validation strategies for processes, systems, and equipment, ensuring alignment of validation activities with regulatory requirements and industry best practices
• Conduct risk and impact assessments to determine the criticality of systems, process and equipment, identify validation requirements, and establish the required validation documentation
• Conduct risk management activities, including Failure Mode and Effects Analysis (FMEA), to identify, assess, and mitigate risks associated with process and equipment validation
• Execute and lead complex validation testing for equipment, utilities, software, and processes, ensuring functionality and performance within defined parameters and providing validation expertise through successful project completion
• Identify and assess opportunities for validation process improvements through data analysis, risk assessments and non-conformance results analysis, to position STEMCELL better from a regulatory and operational standpoint

Knowledge and Qualifications

• Bachelor's degree in Engineering, preferably Mechanical, Chemical, Electrical, Software, or Biomedical, with 6-10 years of relevant experience, or a Master's degree with 4+ years of relevant experience; Certified Quality Engineer preferred and P.Eng. designation considered an asset
• Knowledge of a broad range of mechanical, chemical, electrical and software engineering disciplines, with experience applying engineering principles to manufacturing and product development
• Experience with Enterprise Resource Planning and Quality Management Systems, ideally within an ISO 13485 or GMP-regulated environment; experience in sterile and high-volume manufacturing, Consumer Packaged Goods, pharmaceuticals, cannabis, cosmetics, or similar highly regulated industries is preferred. Ability to understand and assess complex designs and manufacturing requirements is required
• Working knowledge of regulatory standards and quality requirements, including ISO 13485, FDA 21 CFR Part 820, and ISPE, with experience developing risk documentation and applying risk-based validation approaches and statistical methods to establish processes that support manufacturing products in accordance with design inputs and specifications
• Strong organizational, prioritization, and project management skills, with the ability to assess complex designs and manufacturing requirements and support products in accordance with specifications

#LI-KK1 #LI-Onsite #Bench

This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities.

The annual salary for this job ranges from:
$94,600.00 - $142,000.00

STEMCELL determines an individual's pay within the range based on multiple factors including experience, education, job-related skills, and equity within the team or organization. For jobs that are eligible for sales incentives, the range noted above is inclusive of target incentives; actual incentives are based on individual performance results in accordance with company policy. In addition to base salary, STEMCELL offers a comprehensive total rewards package including health benefits, retirement savings, and more.

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