Validation Engineer

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:

Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.

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