Validation Engineer – Siemens Healthineers
Join us in pioneering breakthroughs in healthcare with a focus on sustainability, diversity, and professional growth. This role is based in Sudbury, England, United Kingdom and is part of the Point of Care Diagnostics business line within the Engineering department.
Key Responsibilities
* Ensure 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 to demonstrate compliance.
* 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 support the selection, installation, and commissioning of new equipment.
Core Competencies & 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 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.
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 Sciences, or Medical Devices.
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 flexible benefits ranging from private medical insurance to dental cover.
* Corporate Social Responsibility opportunities, including 2 paid volunteering days per year and support from a 24/7 employee assistance programme.
Who We Are
Siemens Healthineers employs more than 71,000 highly dedicated professionals across more than 70 countries. We lead in medical technology, constantly pushing boundaries to improve patient outcomes and experiences worldwide.
How We Work
We value diverse perspectives and foster a collaborative global team of scientists, clinicians, developers, researchers, and specialists who share a common purpose: to pioneer breakthroughs in healthcare for everyone, everywhere, sustainably.
Equal Opportunity Employer
As an equal opportunity employer, we welcome applications from individuals with disabilities.
Seniority Level: Mid‑Senior Employment Type: Full‑time
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