Job Details

Equipment Specialist, GMP

Title
Equipment Specialist, GMP
Length
Full Time
Employer

STEMCELL Technologies

Salary
Yearly
not disclosed
Location
Vancouver, BC
British Columbia
Date Posted
07/02/2018 - 06:15
Closing Date
07/03/2018 - 06:15
Accepting BioReady
Yes
Job Description
Summary: 

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.

The Equipment Specialist within the Facilities department is responsible for supporting STEMCELL’s equipment management program and its ongoing maintenance activities of manufacturing and laboratory equipment. This role requires an individual who is mechanically inclined to calibrate, inspect, test, qualify, and maintain equipment, in addition to providing technical guidance and support within STEMCELL’s facilities.

Education & Qualifications: 
  • Bachelor of Science and/or technical certification or diploma in instrumentation
  • Minimum 5 years of relevant experience, preferably in a regulated manufacturing environment
  • Strong mechanical, electrical and/or electronic aptitude
  • Comprehensive knowledge of equipment calibration and their applications, including commissioning, test standards, troubleshooting, repairs and optimization of manufacturing and/or laboratory equipment
  • Thorough understanding of regulatory documentation requirements and standard practices, ISO compliance, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Design Control and Workers Safety
  • Customer-focused mindset with strong interpersonal skills
  • Excellent communication skills (verbal, written and presentation) both in one-on-one and in group settings
  • Detail-oriented and proficient at time management
  • Team orientated – ‘one-team’ behavior is a must
Duties & Responsibilities: 
  • Perform in-house equipment calibration, testing, qualification, preventative and predictive maintenance, and improvements or modifications of manufacturing and laboratory equipment
  • Track, schedule calibration, log and maintain equipment records as per established requirements
  • Provide technical guidance and assistance for manufacturing and laboratory equipment repairs; coordinate with external service providers
  • Perform trouble-shooting activities, provide recommended solutions and assist with process improvements
  • Execute on planned maintenance and calibration activities, and document work as required in STEMCELL’s Quality Management System (QMS)
  • Commission and document new equipment arrival
  • Write, review and execute technical documents including qualification protocols (IQ, OQ, PQ), Standard Operation Procedures (SOPs), work instruction, reporting, etc.
  • Manage project-based tasks and lead by defining scope, timelines, resources, etc.
  • Ensure the equipment database is up-to-date
  • Operate the Environmental Monitoring System
  • Respond 24/7 to equipment emergency call-out alarms
  • 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
Other Information: 

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 significant career development opportunities. If you are interested in this challenging and rewarding position, please apply online at https://jobs.stemcell.com/