Job Description SummaryAre you a Quality Engineer experienced in risk-based validation within cGMP environments? Join our team to support processes, analytical methods, and equipment lifecycle verification.
In this role, you will be responsible for generating and supporting higher level project documentation, such as master plans, schedules, risk assessments, protocols, and summary reports. This is a highly collaborative position, and you will work on the full range of project phase execution, including commissioning, qualification, validation, and project hand-over activities, within a variety of departments (e.g. Manufacturing, Quality Control, Process Development, and Instrumentation). This is your chance to work alongside motivated and intelligent individuals who are passionate about the work they do to support life science research.
Job DescriptionDuties and Responsibilities
- Responsible for the development of metrics that report on the effectiveness of processes, status of improvement opportunities and progress against performance objectives to drive continuous improvement
- Participate in the Process Performance Qualification (PPQ) conformance lot manufacturing that includes increased testing to demonstrate acceptability of the developed formulation and process; perform non-conformance and CAPA investigations as needed
- Prepare, review and/or coordinate the execution of validation, commissioning and qualification documentation
- Ensure appropriate procedures, processes and policies are established and implemented for quality assurance activities to assure compliance with applicable medical device and/or biopharmaceutical regulations and products
- Educate, train, advise and coach other employees to ensure adherence to all applicable quality standards for assigned areas
Knowledge and Qualifications
- Bachelor’s Degree in Biomedical Engineering or equivalent, in combination with suitable experience (2-6 years) in a validation job and familiarity with risk management (ISO 14971 and cGMP are an asset)
- Experience in utilities, facilities, and equipment qualification (Manufacturing, Quality Control Lab, Controlled Temperature Chambers mapping and monitoring), as well as software assurance
- Excellent technical report writing and strong ability to understand and analyze technical documents
- Familiar with Continued Monitoring and Improvement concepts
- Strong project management and time management skills, with professional certifications such as ISPE Membership, Project Management, ASQ/Six Sigma Certification or equivalence is an asset
#Nonbench #LI-Onsite #LI-ML1
The annual salary for this job ranges from:
$84,100.00 - $113,700.00
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.
