Job Details

GMP Manufacturing Technologist, Clean Room

Title
GMP Manufacturing Technologist, Clean Room
Accepting BioReady
Yes
Length
Full Time
Employer

STEMCELL Technologies

Salary
Yearly
not disclosed
Location
Vancouver
British Columbia
Date Posted
21/03/2018 - 09:45
Closing Date
21/04/2018 - 09:45
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 Cleanroom Technologist is an integral member with relevant life sciences manufacturing experience and familiarity with aseptic processes in a cGMP regulated environment. This individual must perform fast-paced operations and repeatedly perform multi-step simultaneous operations with a high degree of accuracy. Must follow job Safety, cGMP operations (when required) and compliance requirements. Must be able to communicate effectively while work effectively in a group and independently. Must be able to meet aseptic gowning qualification requirements (when required). This individual will work collaboratively with STEMCELL’s Quality Control, Supply Chain and Quality Assurance departments to effectively produce and deliver high quality products to our customers.Must be able to work weekends, holidays and overtime as required.

Education & Qualifications: 
  • BSc in one of life sciences (ie. Biochemistry, Chemistry, Cell biology) or equivalent degree
  • Working knowledge of GMP environment an asset
  • Intermediate skill level in Microsoft Office applications (for example, Word, Excel, Powerpoint, Sharepoint, Visio, Access and Project)
  • Knowledgeable on quality systems such as ISO 13485. cGMP experience a definite asset
  • Excellent verbal and written communication skills
  • Ability to balance speed and accuracy requirements
  • Ability to lift 25 to 30lbs in cold room environment
  • Ability to work in a fast paced environment. Exposure to Lean Principles a definite asset
Duties & Responsibilities: 
  • Aseptic manufacturing in a clean-room environment, understanding of compliance regulatory standards for ISO 05/07/08 classification
  • Safely use standard production equipment including, but not limited to, personal safety equipment, balances, volumetric glassware, pumps, filters, general production equipment, test equipment, and pipettes
  • Accurately complete batch record documentation, all appropriate logbook entries, and GMP documentation (when required)
  • Follow Standard Operating Procedures, Safety Policies, and current Good Manufacturing Practices to ensure compliance is met
  • Performs routine processes related to bulk formulation and aseptic filling (ex. aseptic processing, not limited to aseptic filtration, aseptic fill, preparation of ISO 5 environment)
  • This includes but is not limited to: working inside Cleanroom suite for several hours at a time, weighing, measuring and checking raw materials to ensure batches manufactured contain proper ingredients and quantities, cleaning equipment located in ISO 5 as per approved procedures, performing repetitive tasks while gowned (hood, mask, coveralls, shoe covers, gloves, etc), may assist with validation activities by executing applicable protocols.
  • Shift work will be required.  needed
  • Occasional weekend work (Saturday and/ Sunday) may be required
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/