Validation Engineer - Fue

Job Posting Start Date: 05/01/2023

Job Posting End Date: 12/22/2023

Description:

Validation initiatives involving facilities, utilities, equipment and computerized systems supporting Research & Development GMP activities are in compliance with Regulatory and Global Quality policies and standards.

The purpose of this position is to ensure that all validation initiatives involving facilities, utilities, equipment and computerized systems supporting Research & Development GMP activities are in compliance with Regulatory and Global Quality policies and standards. This is achieved through active participation on Engineering, ITS and validation project teams. This involves the assessment of 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. Validation status is then maintained through participation in the change control process (identifying appropriate revalidation where appropriate). Providing technical quality support to various user groups including IS, purchasing and Global/Site Engineering and Maintenance. Collaboration with the various groups is essential to the success of achieving and maintaining compliant facilities, utilities, equipment and computerized systems.

Key Accountabilities

Computerized / Non-Computerized Equipment, Process, Facility and Utility Validation 55%

• Ensure that the methodology used in qualification testing will thoroughly test and challenge applicable system/facility
• Provide technical support to the design and configuration of various systems
• Provide final review and approval of all system/facility validation, design and execution documentation
• Ensure validation is in compliance with 21 CFR part 11 and Annex 11 (where applicable)
• Review and approve development documentation for GMP compliance, business risk, and consistency.
• Represent Quality on capital projects, understanding of facility/utility drawings and impact to GMP operations
• Provide quality support to the evaluation of: software applications associated with computerized systems
• Provide and monitor non-conformance results during the validation studies to determine acceptable remediation/corrective actions
• Lead/manage/participate in global alignment projects for validation and compliance
• Advise on test requirements, scope, and acceptance criteria as per project deliverables
• Assess quality risk associated with changes to: equipment, facilities, utilities and processes for clinical manufacturing

Project Team representation 25%

• Provide subject matter expertise during External and Internal Regulatory Inspections defending the programs and the individual validated equipment/systems and providing timely and technically completed responses to audit observations.
• Coordinate with project team members the performance of Commissioning and Qualification activities as per the designated validation plan and protocols.
• Represent Quality Operations on key company projects to endure project deliverables are attained from a validation and quality perspective.
• Provide Quality engineering support in the selection of vendors, participate in assessment of system design/redesign

Collaboration on Local & Global Quality Initiatives 10%

• Participates in local customer service initiatives including those focusing on improving R&D SQO support.
• Participates in global SQO networks (such as FUE – Facilities, Utilities, Equipment)
• Keeps updated on new rules and industry regulations, and to define and align internal quality systems with best practices.
• Responsible for identifying opportunity for improvements to quality processes through the review and evaluation of quality metrics and recommending appropriate resolutions.
• Participates in global R&D SQO initiatives impacting quality systems to ensure harmonization of processes. Works with global R&D SQO colleagues on action plans for remediation and/or implementation.

Audits 5%

• Ensure all required documentation to be provided by vendor/consultant will allow Sanofi Pasteur Canada to be self - reliant and compliant
• Perform Vendors’ and in-house audits (approximately 10 - 15 % Travelling)

Training & Interactions 5%

• Develop and maintain site policies and procedures that describe validation initiatives that are aligned to regulatory requirements and global Quality and Industry standards. Update and/or provide training to users on validation policies and procedures.
• Development documentation consists of specifications, protocols, plans, training material and SOPs for systems including stand alone and custom built systems (ie. Automated systems, Analytical tests equipment including macros for calculations methods).

CONTEXT OF THE JOB/MAJOR CHALLENGES

• Incumbent must remain current of changing regulatory environment and new approaches to validation, commissioning & qualification design/approaches.
• Incumbent must understand computer validation methodologies such as to define the extent of validation based in intended use and/or risk assessment
• The incumbent must be familiar with changing regulatory environments in computer validation (i.e. 21 CFR Part 11, Annex 11, ASTM 2500 Verification, Key Industry Standards in Automation).
• Incumbent must collaborate closely with User groups including Site/Global engineering, maintenance and IS to ensure compliant validation strategies and ensure systems remain compliant throughout their lifecycle.
• The incumbent must be able to defend programs and provide professional and technical support during corporate and external regulatory inspections in a competent and convincing manner.
• Incumbent must understand the engineering procurement and design methodologies
• The incumbent must provide to users, Site/Global engineering and purchasing; quality and technical support related to the evaluation and purchase of equipment (computerized/non-computerized) and business processes

DIMENSIONS/SCOPE

• The accountabilities of this position are local as well as global. This position is primarily 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.
• Incumbent will also work in global environment in development test practices and supporting the development of global Quality documents and standards supporting validation.
• This is a managerial position. There are no direct reports into the position, however whenever applicable guidance will be provided to junior staff and consultants.
• All operating areas in R&D and Clinical Manufacturing/Testing as well as some business support areas including Information Systems.

Requirements

• Minimum, B.Sc. or Equivalent in Computer and/or Engineering Sciences.
• Degree in MBA and certifications in Project Management and/or Six Sigma is an asset
• Professional Engineer designation is an asset
• Formal training in commissioning/qualification and validation is an asset.
• Ability to read/write French is a plus

Industry Experience

• Experience in commissioning and qualification of equipment (computerized/non-computerized) and facilities
• Evaluate System Suitability based on Functional and Design Specifications
• Selection of Vendor and perform audits
• Experience in project management (as it relates to commissioning/qualification deliverables)
• Five to seven years related job experience required
• Experience/knowledge in validation design/approach and System Development Life Cycle (SDLC)
• Excellent problem solving, report writing and communication skills
• Read configuration, network and connection diagrams
• Good knowledge of Quality Systems/Practices
• Experience of manufacturing environments (equipment/facilities/utilities) for biologics
• Read and understand engineering P&ID diagrams
• Practical knowledge of vaccine manufacturing.

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