Automation and Digital Projects Specialist

** Work Schedule*
* Standard (Mon-Fri)

** Environmental Conditions*
* Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

** Job Description*
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* Summary:

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* Reporting into the Digital Transformation department within Manufacturing Science and Technology (MSAT), the Automation and Digital Projects Specialist supports the planning, designing, development, and execution of automation and digital transformation initiatives that improve operational efficiency, compliance, and business performance. The role independently leads projects and supports larger cross-functional initiatives by facilitating business requirements, coordinating stakeholders, managing project deliverables, and assisting with design, implementation, software validation, and change management activities.

Working closely with Operations, Quality, IT, Engineering, and business stakeholders, this individual ensures digital solutions are implemented and maintained in accordance with company standards and applicable regulatory requirements.

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* Essential Functions:

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* Lead automation and digital projects from initiation through implementation while supporting larger strategic initiatives, as required.
Facilitate workshops and working sessions to gather business requirements and document current and future state processes. Define use cases in detailed User Requirement Specification (URS) documents.
Develop project plans, monitor timelines, risks, and project deliverables while communicating status to stakeholders. Coordinate cross-functional teams, vendors, and technical resources to support successful project execution.
Design, configure, develop, test, and deploy automation and digital solutions that streamline business processes, improve data quality, eliminate manual activities, and enhance operational performance.
Coordinate User Acceptance Testing (UAT), support test planning and execution, and assist with issue tracking and resolution.
Support adoption of automation and digital solutions that support business process improvement principles including operational efficiency, quality, compliance, and data integrity.
Identify process improvement opportunities and support continuous improvement initiatives throughout project lifecycle.
Support Computer System Validation (CSV) activities for GxP computerized systems through technical documentation reviews, protocol coordination, execution support, and lifecycle documentation support including periodic reviews, user access reviews, and audit trail reviews.
Utilize Quality Management Systems (QMS) for generation of change controls, deviations, and CAPAs, as required.
Maintain a safe working environment and report potential hazards.

** REQUIRED QUALIFICATIONS*
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* Education:

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* Post secondary diploma in Engineering, Science, Computer Science, Information Technology, or a related discipline.
Bachelor's degree in computer science or engineering is an asset.

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* Experience:

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* Minimum 3 years of relevant experience leading or supporting projects involving digital technologies, automation, business process improvement, project management, or computer system validation within a regulated environment.
Minimum 2 years Information Technology expertise and experience with IT Infrastructure and IT Application implementations.
Exposure to pharmaceutical environment an asset. Project Management experience is asset.

** Equivalency:*
* Equivalent combinations of education, training, and relevant work experience may be considered.

** Knowledge, Skills, and Abilities:*
* Working knowledge of Good Manufacturing Practices (GMP), GAMP 5, 21 CFR Part 11, and computer system validation principles. Understanding of automation concepts, system integrations, APIs, data flows, and software implementation life cycles with digital solution product development. Experience designing and implementing business process automation solutions using low-code/no-code platforms, scripting, reporting tools, or similar digital technologies. Familiarity with User Requirement Specification (URS) generation and User Acceptance Testing (UAT), software implementation, and change management.

Excellent written and oral skills with ability to translate business requirements into practical digital or automated solutions through facilitations and workshops. Ability to communicate technical concepts to non-technical audiences and vice-versa. Knowledge of waterfall and agile project management methodologies and software implementation life cycles. Strong analytical, organizational, problem-solving, and stakeholder management skills. Strong judgment, decision making and troubleshooting skills. Ability to multi-task, meeting tight deadlines in a fast-paced environment.

Proficiency with Microsoft Office programs. Proficiency with the English Language.

** Standards and Expectations: *
* Follow all…