Laboratory Equipment

PharmEng Technology is currently seeking a Laboratory  Equipment to join our team for projects in Toronto, ON. The position is available immediately conditional of a successful interview.
 
Job Description:
  • Laboratory equipment qualification project management including computerized software through developing overall project plan, monitoring the project progress, communicating with all stake holders, and working with each individual department to ensure the projects meet the overall timelines
  • Propose the scope of works for lab equipment qualification including user requirement specification, functional design specifications, risk assessment protocols, sourcing and receiving the equipment, internal utility preparation, computer software and equipment installation,  vendor’s IQOQ and reports, in-house qualification protocols and reports, SOP approval and training for different lab equipment
  • Source necessary equipment and/or parts to assist the equipment validation and daily calibration. Work with vendors to prepare quote for analytical equipment and coordinate with vendor and metrology department for the vendor’s IQOQ execution.
  • Work with internal department to install the equipment including facility and utilities.
  • Lead a validation groups and monitor the progress of their validation activities to meet the monthly requirements
  • Prepare vendor qualification documents for lab equipment vendors.
  • Prepare documents to close-out form to close the lab equipment related projects
  • Coordinate with multiple sites including international sites for SOP training to meet the project timeline.
  • Work with internal related departments including metrology, equipment owner and QA departments to resolve non-conformance issues for lab equipment validation such gas chromatography, HPLC, dissolution apparatus, glassware washer, autosamplers, etc.
  • Responsible for other duties as assigned

Job Requirements:
  • Minimum of Bachelor’s Degree in Sciences or related field
  • Minimum of 5 years of experience in laboratory equipment validation in pharmaceutical industry, such as HPLC, GAS chromatography, Karl Fisher Titrator, and Refractometer, auto-sampler, dissolution apparatus, FTIR, UV and glassware washer
  • Knowledge and experience of SOP, GMPs, cGMPs and compliance
  • Experience with computerized software validation and computer system validation and familiar with 21 CFR Part 11 including data integrity
  • Superior project management, communication both in written and oral and interpersonal skills
  • Ability to work in cross functional teams and multiple sites
  • Able to travel between sites
 
 
Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.
 
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