Apply now for the position of Validation Engineer within the Point of Care Diagnostics business line at our facility in Sudbury. You will be part of the Engineering department driving effective Process Management, continuous improvement, and providing engineering/technical support for manufacturing operations. Your responsibilities include managing and supporting validation activities across all functions with a key emphasis on process, equipment, and computer system validation and technical support.
Your Role
* 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 and 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 to demonstrate that we have compliant systems.
* Maintain compliance with Data Integrity Regulations, GAMP standards, 21 CFR Part 11, and applicable regulatory guidelines.
* 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: 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, or Medical Devices.
Our Benefits
* 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.
How we work
When you join Siemens Healthineers, you become part of a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists who believe in each individual’s potential to contribute diverse ideas. We come from different backgrounds, cultures, religions, political 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.
As an equal‑opportunity employer, we welcome applications from individuals with disabilities. We care about your data privacy and take compliance with GDPR and other data protection legislation seriously.
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