Danaher Corporation Computerised Systems Validation Engineer in Little Chalfont, United Kingdom
Be part of something altogether life-changing
Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
What you’ll do
Support the CSV Leader in implementation of the risk-based approach to CSV system, in line with the regulation and ensuring QMS compliance
Lead the CSV support in key global projects concerning computerised system,
Participating in the delivery of systems solutions by overseeing/reviewing SDLC/CSV/Qualification activities
Providing validation/verification/qualification guidance to stake holders as necessary
Overseeing execution validation/qualification/verification/migration strategies per Cytiva CSV procedure(s).
Managing relationships with key customers and stakeholders to ensure oversight that the total validated/verified/qualified solution delivered, meet/exceed expectations.
Ensuring SDLC/CSV/Qualification activities are conducted in a compliant and timely manner.
Working closely with the CSV Leader and Validation Manager to support the roll out of the CSV training and education
Project manage key project where QA is the functional system owner
Support projects on systems hosted in SaaS or PaaS
Who you are
Bachelor's Degree and minimum of 5 years working in a Quality role in regulated medical device pharmaceutical or life sciences industry in roles specific to CSV
Quality Assurance/ Quality Engineering experience in CSV in a GMP environment is essential, proficiency on GAMP 5 and FDA and EU regulations
Understanding Medical Devices QMS and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485 and ISO 9001 will be advantage
Understanding of data integrity compliance and experience in Implementation of the electronic Document Management System and electronic Quality Management System would be advantageous.
Excellent organizational, presentation, meeting facilitation and report writing skills
Demonstrated good collaboration skills and expertise to effectively communicate
When you join us, you’ll also be joining Danaher’s global organization, where 68,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
If you’ve ever wondered what’s within you, there’s no better time to find out.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .