Validation Engineer III

Validation Engineer Toronto
Introduction
The Validation Engineer will be responsible for validating all initiatives involving facilities, utilities, equipment, and computerized systems supporting Research & Development GMP activities to ensure that they are in compliance with Regulatory and Global Quality policies and standards. The Validation Engineer will also provide technical quality support to various user groups including IS, purchasing, and Global/Site Engineering and Maintenance, and collaborate with them to ensure the success of achieving and maintaining compliant facilities, utilities, equipment, and computerized systems.

Responsibilities

• Actively participate on Engineering, ITS, and validation project teams
• Assess system vendors and their equipment, ensuring 21CFR Part 11/Annex 11 compliance, review, and approval of test protocols, specifications, facility/P&ID drawings, and reports
• Maintain the validation status through participation in the change control process (identifying appropriate revalidation where appropriate)
• Provide numerical data if available to describe the size of the job or its impact on the business
• Use annual figures and specify currency
• Create figures that include budgetary responsibility, purchasing authority, and resources available
• Highlight the key decisions made in this job by outlining the sphere of the job, such as whether the accountabilities are global, country-specific, or function-specific
• Accountable to local Research and Development, however, decisions made and actions taken may have an impact on all departments at the Canadian and French R&D sites with respect to Equipment, Facilities, Utilities, and Computer Systems
• All operating areas in R&D and Clinical Manufacturing/Testing as well as some business support areas including Information Systems.
• Work in the global environment in the development of test practices and supporting the development of global Quality documents and standards supporting validation

Requirements

• Minimum, B.Sc. or Equivalent in Computer and/or Engineering Sciences
• 5 - 7 years of related job experience required
• Experience of manufacturing environments (equipment/facilities/utilities) for biologics
• Experience/knowledge in validation design/approach and System Development Life Cycle (SDLC)
• Experience in commissioning and qualification of equipment (computerized/non-computerized) and facilities
• Experience in project management (as it relates to commissioning/qualification deliverables)
• Formal training in commissioning/qualification and validation is an asset
• Degree in MBA and certifications in Project Management and/or Six Sigma is an asset 
• Professional Engineer designation is an asset 
• Ability to read/write Frenchs a plus 
• Evaluate System Suitability based on Functional and Design Specifications 
• Selection of Vendor and perform audits 
• Read configuration, network and connection diagrams 
• Read and understand engineering P&ID diagrams 
• Excellent problem solving, report writing and communication skills 
• Good knowledge of Quality Systems/Practices 
• Practical knowledge of vaccine manufacturing