Equipment Qualification Specialist

2 weeks ago

Burnaby, Canada STEMCELL Technologies Full time

**Job Description Summary**:
Are you a real team player who is eager to keep building on your technical skill set and looking to be part of the largest biotech company in Canada with almost 30 years of cutting edge products and technology.

Here at STEMCELL Technologies we are looking for the next Equipment Qualification Specialist to join us This role is key for the operation of the company, as you will be responsible for supporting STEMCELL’s equipment management program and its ongoing qualification activities of manufacturing and laboratory equipment.

**Duties and Responsibilities**
- Perform qualification of laboratory instruments/equipment in accordance with STEMCELL's Quality Management System (QMS)
- Collaborate with laboratory personnel, Vendor Technician, and Instrument Service to define qualification requirements
- Author, review and execute qualification protocols (IQ, OQ, PQ), Standard Operating Procedures (SOPs), User Requirements Specifications, Functional Acceptance Test, and others as needed
- Coordinate equipment qualification activities with vendors and site support groups (e.g., procurement, equipment maintenance team, and laboratory personnel)
- Ensure adherence and implementation of company policies, SOPs, Quality and Safety Programs, ISO compliance, Good Laboratory Practices (GLP) and Good Manufacturing Practice (GMP) standards and regulations when fulfilling all equipment related activities

**Knowledge and Qualifications**
- Bachelor of Science in Physics or Engineering field and 6+ years of relevant experience, preferably in a regulated manufacturing environment
- Strong mechanical, electrical and/or electronic aptitude
- Experience with equipment qualification life cycle, execution, reporting and analyzing data
- Thorough understanding of regulatory documentation requirements and standard practices, ISO compliance (13485), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Design Control and Workers Safety

**#United #LI-Onsite**

STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. 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, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” - standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada.

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 Canada’s 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.

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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