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

Summary:

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.

Essential Functions: 

• 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

Education:

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.

Experience:

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 lifecycles 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 lifecycles. 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 Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.  Effectively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Model positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner.  Consistently strives to improve skills and knowledge in related field.    

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

Disclaimer: 

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Compensation

The estimated annualized pay range for this position in Ontario is $62,000.00–$82,700.00.