Senior Quality Engineer, Validation

STEMCELL Technologies•Burnaby, BC

1d•CA$94,600 - CA$142,000•Onsite

About The Position

STEMCELL Technologies’ Quality Assurance Validation team is growing and we are looking for a Senior Quality Engineer, Validation to join our team! 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.

Requirements

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
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
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

Nice To Haves

Certified Quality Engineer preferred
P.Eng. designation considered an asset
experience in sterile and high-volume manufacturing, Consumer Packaged Goods, pharmaceuticals, cannabis, cosmetics, or similar highly regulated industries is preferred

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