Position Details 

Job Title                                             Manufacturing Validation Engineer

Department                                        Engineering

Reports To Title                                 Supervisor, Validation

Supervise Direct Reports                 No

Shift                                                    Day Shift - 8:00 to 16:30

Introduction

We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.

General Responsibilities

Provide engineering and validation guidance to support the design, implementation, qualification, and ongoing compliance of manufacturing systems, equipment, facilities, and utilities. This role exists to ensure engineering projects are executed safely, efficiently, and in accordance with regulatory, quality, and site requirements while maintaining systems in a validated state throughout their lifecycle. By driving validation strategies, managing project execution, and assessing the impact of operational changes, the position contributes to reliable manufacturing operations, regulatory compliance, continuous improvement, and overall business performance.

Key Responsibilities

• Lead engineering studies and apply sound engineering principles to develop and implement improvements for existing and new manufacturing systems and processes.
•  Identify and drive opportunities to enhance productivity, operational efficiency, and reliability through optimization of technology, equipment, and energy utilization.
• Develop and execute validation strategies in accordance with industry best practices, site procedures, and applicable regulatory and safety requirements.
• Author, review, and maintain validation documentation, including User Requirement Specifications (URS), Enhanced Design Reviews (EDR), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
• Manage validation projects from initiation to completion, utilizing project management principles to coordinate scope, schedules, resources, budgets, timelines, risks, and reporting requirements.
• Ensure compliance with current Good Manufacturing Practices (cGMP), corporate policies, and all applicable regulatory and quality requirements.
• Conduct periodic reviews of validated systems and equipment to verify continued compliance, performance, and fit for intended use throughout the system lifecycle.
• Evaluate and support the implementation of new equipment associated with product transfers and continuous improvement initiatives.
• Ensuring compliance with applicable safety standards, regulatory requirements, and site safety policies.

Education & Experience Requirements

• Bachelor’s degree in science or engineering - preferably with a focus on mechanical, industrial, electrical, or computer engineering or Technical Diploma
• 3 – 5 years’ experience in pharmaceutical, food or other regulated manufacturing industry.
• Experience with validation plans and qualification protocols.

Technical and Professional Requirements

• Strong technical writing skills with prior experience in equipment validation.
• Fundamental understanding of mechanical, electrical, and control systems is a desired qualification
• Proven ability to manage multiple concurrent projects in a fast-paced environment.
• Knowledgeable in applicable regulatory guidance on validation, qualification, and sterile drug manufacturing.

Core Competencies

• Effective interpersonal and communication skills.
• Ability to collaborate and engage with stakeholders at all levels of the organization.
• Strong self-motivation and a proactive approach.
• Strong attention to detail.
• Problem-solving and critical thinking mindset
• Adaptability in a fast-paced environment.
• Accountability and ownership of projects.
• Continuous learning and compliance mindset.

Total Rewards

The range of starting base pay for this role is 82,000 – 107,000 CAD. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

What we have to offer employees at our site:

• Health insurance commences upon start date
• Employee Assistance Program (EAP)
• Employee Recognition Program
• Full-service cafeteria with weekly lunch specials; free coffee and tea
• Free energized parking
• Free electric vehicle parking
• Annual bonus plan
• Employee Stock Purchase Plan (ESPP) for qualifying employees
• Registered Retirement Savings Plan (RRSP & DPSP) for qualifying employees
• Free onsite gym
• Tuition reimbursement
• Years of Service Awards
• Employee Referral Program
• Maternity Leave top-up
• Apprenticeship Leave top-up