Computer System Validation Engineer - Pharmaceutics
PharmEng Technology - Toronto, ON

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Company Description
PharmEng Technology is an international full service consulting firm that services pharmaceutical, biotechnology, medical device, nutraceutical, heath care and chemical sectors. PharmEng Technology has a proven track record of excellence which ensures all of client needs and governing regulatory expectations are met and exceeded.

PharmEng Technology provides services in:

  • Commissioning & Qualification
  • Validation (Manufacturing, Lab)
  • Serialization
  • Engineering
  • Regulatory Affairs
  • Quality systems
  • Training/Teaching

As a fast pace fast growing consulting firm we are always looking for qualified scientists and engineers with the ability to create and communicate innovative and cost effective solutions to clients. This is a great opportunity to obtain a challenging career that enables you to work closely with major international clients and travel the world!

We currently have projects all over the world in Canada, USA, Europe and Asia.

Roles and Responsibilities

  • Develop and execute validation protocols (IQ/OQ/PQ).
  • Prepare validation documents: capture functional requirements for the client, change control, standard operating procedures (SOPs) and reports etc.
  • Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control etc.
  • Perform administration, monitoring, troubleshooting and upgrades to the corporate File, Printing, Internet access, Web and E-mail services.
  • Develop SOPs and training manuals. Conducting validation activities at client sites.
  • Maintain personal training records. Ensure compliance with relevant regulations (e.g. cGMP/GLP/GAMP/GALP). Complete assigned projects and tasks within agreed deadlines.
  • Assessment of client computer systems in terms of FDA 21CFR Part 11 compliance

Requirements

  • Bachelor’s or Masters Degree in Electrical Engineering or Computer Science
  • Working knowledge of Trackwise and Global i-Track
  • Experience with Microsoft SQL
  • Working knowledge of regulations (cGMP – FDA 21CFR Part 11, Good Automated Manufacturing * Practice (GAMP4), GLP and Good Automated Laboratory Practice (GALP)) and current industry practices in hardware/software validation and computerized systems such as SAP, LIMS, automated DCS, BMS, Delta V etc.

Other Requirements

  • Willingness to travel
  • Holds a valid driving license and passport
  • Must be able to legally work in USA

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