Senior Commissioning and Qualification Engineer I

STEMCELL Technologies, Inc.

$94K — $142K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree with 6-10 years of relevant experience
  • Professional Engineering (P.Eng) designation preferred
  • Expertise in commissioning and qualification lifecycle
  • Familiarity with GMP validation and documentation
  • Experience in risk assessment and deviation management
  • Knowledge of regulatory compliance standards

Responsibilities

  • Manage commissioning and qualification activities for facilities and equipment
  • Recommend and review validation protocols and SOPs
  • Collaborate with teams and vendors to organize qualification activities
  • Evaluate qualification results and support corrective actions
  • Oversee compliance with policies, regulations, and quality standards

Benefits

  • Comprehensive health benefits
  • Retirement savings plan
  • Supportive multidisciplinary team environment
  • Hands-on role with significant technical responsibilities
Full Job Description
Job Description Summary

In this role, you will lead the commissioning, qualification and validation activities for our facilities, utilities and laboratory equipment. You will provide support to ensure compliant and reliable operations are maintained. You will also contribute technical expertise and cross-functional coordination to support successful system qualification and operational readiness. This is an exciting opportunity for someone who is looking for a hands-on role within a multidisciplinary, solution-driven team.

Job Description

Duties and Responsibilities

  • Manage commissioning and qualification activities for facilities, utilities, equipment, and support systems in accordance with approved plans, procedures, and quality requirements

  • Recommend and review validation protocols, standard operating procedures (SOPs), and technical reports

  • Collaborate with cross-functional teams and external vendors to organize qualification activities and support project schedules

  • Evaluate qualification results, identify deviations from expected outcomes, and support implementation of corrective actions in accordance with established procedures

  • Oversee compliance with company policies, regulatory guidelines, quality standards, and safety procedures

Knowledge and Qualifications

  • Bachelor's degree with 6-10 years of relevant experience

  • Professional Engineering (P.Eng) designation preferred

  • Commissioning and qualification lifecycle expertise

  • GMP validation, documentation and data integrity practices

  • Risk assessment and deviation management

  • Regulatory compliance knowledge

#NonBench #LI-Onsite #LI-KP1

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.

To apply, please select the “Apply” button below. You will then be directed to a login screen asking you to set up an account, which is required to apply.​​

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