Senior Quality Engineer, Validation

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

• Bachelors degree in Engineering preferably Mechanical Chemical Electrical Software or Biomedical with 610 years of relevant experience or a Masters degree with 4 years of relevant experience; Certified Quality Engineer preferred and . 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

STEMCELL Technologies is a privately owned Vancouver-based biotechnology company that helps power leading-edge life science research around the world. Driven by our love of science and passion for quality we are a company of Scientists Helping Scientistsstanding by our customers to provide the outstanding products technical support and training they need to advance their research. Scientists performing stem cell immunology cancer regenerative medicine and cellular therapy research are among those who rely on our cell culture media cell separation products instruments accessory products and services. Through our many regional offices as well as our distribution centers in Vancouver Seattle Grenoble and Singapore we deliver our innovative specialized products to more than 100 countries. With over 1800 employees globally most with scientific or engineering degrees STEMCELL is proud to be the largest biotechnology employer inCanada.

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.

STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canadas Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact.

As an equal opportunity employer STEMCELL is dedicated to ensuring that every employee feels safe valued and respected for who they are. We know that scientific progress and innovation occur when diverse creative minds come together and we are committed to nurturing a culture of inclusivity and belonging. STEMCELL enforces a zero-tolerance policy for any form of discrimination. Selection decisions are solely based on job-related factors.

The annual salary for this job ranges from:

STEMCELL determines an individuals 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 addition to base salary STEMCELL offers a comprehensive total rewards package including health benefits retirement savings and more.

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