Do you want to contribute to the future of healthcare? Siemens Healthineers value those who dedicate their energy and passion to this cause, our company's name is dedicated to our employees. It's their pioneering spirit, blended with our long history of engineering in the ever evolving healthcare industry that truly makes us unique as an employer.
We offer you a flexible and dynamic environment and the space to stretch beyond your comfort zone in order to grow both personally and professionally. Sound interesting?
Come and join our team as a Validation Manager to lead and inspire the validation team as part of the extended site leadership. You will be managing a team of 3 people.
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 mission and responsibilities:
Core Validation Requirements
Manage and maintain the Site Validation Master Plan and associated Validation Master Tracker in accordance with GMP.
Chair site Validation Review Board
Preparation and execution of validation protocols. Author, review and approve validation, technical documentation and SOPs.
Assisting system owners with impact assessments and identifying qualification/validation requirements.
Carrying out all validation activities on equipment
Regulatory Requirements 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.
EHS Ensuring compliance with safety, health and environmental (SHE) legislation.
Teamwork Engaging with project teams to help with selection, installation and commissioning of new equipment.
Quality Assurance Competent in the principles of and practical use of the Quality Management Systems.
To find out more about the specific business, have a look at https://www.siemens-healthineers.com/en-uk/point-of-care-testing
Your qualifications and 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).
Proven leadership skills in leading small to medium-sized teams.
Solid project management experience leading small to medium-sized teams in technical projects.
Your personality and skills:
Structured problem solving / investigation skills.
Being part of our team:
Siemens Healthineers is a leading global medical technology company. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.
Your cultural fit:
Our unique team spirit arises from embracing different perspectives, open debate, and the will to challenge conventions. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That's why we want you to seek, implement and celebrate your best ideas.
We recognise that building a diverse workforce is critical to the success of our business. We strongly encourage applications from a diverse talent pool and welcome the opportunity to discuss flexibility requirements with our applicants to encourage agile working and innovation. We can offer different flexible working options at Sudbury depending on the role you're applying for. We're be happy to talk through these options with you during the application process.
Be unique. Be authentic. However you prefer to say it, we really mean it. Our culture
embraces people’s diverse perspectives and creates a positive environment where everyone
belongs. We’re determined to build a better, more connected world for everyone.