Validation Engineer

Siemens Mobility; Northeastern Ontario; On-site; CAD 70,000 - 90,000; Full time

Job summary

A prominent healthcare technology company in Northeastern Ontario is seeking a Validation Engineer to manage and support validation activities, ensuring compliance with safety and regulatory standards. Ideal candidates will have 2–5 years of experience in regulated environments and familiarity with validation protocols and documentation. This is an excellent opportunity for those looking to contribute to healthcare breakthroughs in a dynamic team environment.

Benefits

26 days' holiday, with the option to buy or sell 5 more

Up to 10% employer pension contribution

Share and bonus scheme

Access to flexible benefits like private medical insurance

Corporate Social Responsibility opportunities with paid volunteering days

Qualifications

• Typically 2–5 years in pharmaceutical, medical device, or regulated environments.
• Proven experience in planning, executing, and closing validation projects.
• Exposure to regulatory audits and ability to defend documentation.
• Experience with Lean or Six Sigma methodologies is a plus.

Responsibilities

• Ensure all validation activities follow the Site Validation Master Plan.
• Prepare and execute validation protocols and documentation.
• Assist system owners with impact assessments and validation requirements.
• Maintain compliance with safety, health, and environmental legislation.

Skills

Validation Protocol Development

Regulatory Knowledge

Risk Assessment

Equipment & Process Validation

Computer System Validation (CSV)

Documentation Skills

Education

Degree in Engineering/Pharma/Biotech/Life Science/Medical Devices

Job description

Siemens Healthcare Diagnostics Manufacturing Ltd

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Apply now for the position of Validation Engineer within the Point of Care Diagnostics business line at our in Sudbury.

You will be part of the Engineering department driving effective Process Management, continuous improvement and provide engineering / technical support for manufacturing operations. You will manage and support validation activities across all functions with a key emphasis on providing expertise in all aspects of process, equipment and computer system validation and technical support.

Your Role:

• You will ensure that all validation activities are conducted in accordance with the Site Validation Master Plan (SVMP) and established validation policies and procedures.
• Prepare and execute validation protocols. Author, review and approve validation, technical documentation and SOPs.
• Assist system owners with impact assessments and identify qualification/validation requirements.
• Carry out all validation activities on equipment and systems.
• Represent the business in customer audits and regulatory inspections demonstrate that we have compliant systems.
• Maintain compliance with Data Integrity Regulations, GAMP standards, 21 CFR Part 11 and applicable regulatory guidelines.
• You will ensure compliance with safety, health and environmental (SHE) legislation, and drive a zero-accident culture.
• Engage with project teams to help with selection, installation, and commissioning of new equipment.

Your Expertise:

• Validation Protocol Development: Ability to create and execute IQ/OQ/PQ protocols for equipment, utilities, and processes.
• Regulatory Knowledge: Familiarity with GMP, FDA, MHRA, ISO standards, and other relevant regulatory guidelines.
• Risk Assessment: Experience with FMEA, or similar risk-based approaches.
• Equipment & Process Validation: Hands-on experience with manufacturing equipment, cleaning validation, and process qualification.
• Computer System Validation (CSV): Understanding of GAMP 5 principles and 21 CFR Part 11 compliance.
• Documentation Skills: Strong ability to write clear, compliant validation documentation and reports.

Your Experience & Qualifications:

• Industry Background: Typically 2–5 years in pharmaceutical, medical device, or regulated manufacturing environments.
• Validation Lifecycle: Proven experience in planning, executing, and closing validation projects.
• Audits & Inspections: Exposure to regulatory audits and ability to defend validation documentation.
• Continuous Improvement: Experience with Lean or Six Sigma methodologies is a plus.
• Degree qualified, or equivalent experience in, Engineering/Pharma/Biotech/Life Science/Medical Devices.
• 26 days' holiday with the option to buy or sell an additional 5
• Up to 10% employer pension contribution
• Share and bonus scheme
• Access to our flexible benefits from private medical insurance to dental cover
• Corporate Social Responsibility opportunities including 2 paid volunteering days per year and support from our 24/7 employee assistance programme

Who we are:

We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

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To all recruitment agencies:

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