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.
Join our team now at Siemens Healthineers as a
Validation Engineer
within the Point of Care Diagnostics business line at our Sudbury site. You will be part of the Engineering department driving effective Process Management, continuous improvement and providing engineering/technical support for manufacturing operations. Job Responsibilities: 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. Preparation and execution of validation protocols; author, review, and approve validation, technical documentation, and SOPs. Assist system owners with impact assessments and identifying qualification/validation requirements. Carry out all validation activities on equipment. Represent the business in customer audits and regulatory inspections to demonstrate compliance with 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. Drive a safety-first approach maintaining a zero-accident culture, ensuring accident prevention and environmental protection regulations of the facility to assure a safe and productive working environment free of any liabilities or defects. Engage with project teams to help with selection, installation, and commissioning of new equipment. Be competent in the principles of and practical use of the Quality Management Systems. Skills and Experience: Electrical/Mechanical background would be advantageous. Strong communication and interpersonal skills. Competent in Microsoft Office applications (Excel/Word/PowerPoint/Outlook). Good oral and written communication skills. Demonstrated use of structured problem-solving/investigation skills. Degree qualified or equivalent experience. Extensive validation experience in medical product manufacturing industries. Fluent in cGMP principles. Thorough understanding of regulatory requirements for EMA ISO13485 and US CFR 820. Thorough understanding of the principles of validation (e.g., V Model). Solid project management experience. 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. 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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Validation Engineer
within the Point of Care Diagnostics business line at our Sudbury site. You will be part of the Engineering department driving effective Process Management, continuous improvement and providing engineering/technical support for manufacturing operations. Job Responsibilities: 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. Preparation and execution of validation protocols; author, review, and approve validation, technical documentation, and SOPs. Assist system owners with impact assessments and identifying qualification/validation requirements. Carry out all validation activities on equipment. Represent the business in customer audits and regulatory inspections to demonstrate compliance with 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. Drive a safety-first approach maintaining a zero-accident culture, ensuring accident prevention and environmental protection regulations of the facility to assure a safe and productive working environment free of any liabilities or defects. Engage with project teams to help with selection, installation, and commissioning of new equipment. Be competent in the principles of and practical use of the Quality Management Systems. Skills and Experience: Electrical/Mechanical background would be advantageous. Strong communication and interpersonal skills. Competent in Microsoft Office applications (Excel/Word/PowerPoint/Outlook). Good oral and written communication skills. Demonstrated use of structured problem-solving/investigation skills. Degree qualified or equivalent experience. Extensive validation experience in medical product manufacturing industries. Fluent in cGMP principles. Thorough understanding of regulatory requirements for EMA ISO13485 and US CFR 820. Thorough understanding of the principles of validation (e.g., V Model). Solid project management experience. 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. 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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