Join our Validation team at our Nottingham site.
We are looking for a Validation Specialist to join our Validation department at Sartorius Albumedix Limited. In this role, you will be responsible for writing and executing validation test protocols (IVP, IQ,OQ,IOQ,PQ and VR) for equipment and processes, ensuring compliance with GMP and FDA guidelines. You will be validating all equipment and operations such as Process Qualification, CIP, SIP, Autoclave, Cold store, Thermal Mapping, Cleanroom and Cell Bank Suite.
The team consists of 3 professionals, and we are looking forward to shaping the future with you.
This position is available full-time. It is an onsite role in central Nottingham, and the site is easy to get to, being a short walk from the train station and tram stop.
Grow With Us – Your Responsibilities
* On a daily basis you will write and execute protocols for equipment, facilities, software, and processes to ensure they function as intended and meet regulatory requirements
* Create and maintain detailed validation reports, technical reports, and risk assessments to document activities, results, and compliance.
* Verify that processes and systems adhere to industry standards and regulations, such as Good Manufacturing Practices (GMP) or FDA guidelines.
* Work with cross-functional teams, including Quality Assurance (QA), Engineering and Production to gather requirements, troubleshoot issues, and implement process improvements.
* Perform tests, collect data, and analyse results to provide evidence of system and process validation.
* Identify opportunities for process improvements and assist in their implementation to enhance efficiency and compliance.
* Departmental representation at customer/regulatory audits.
* Using Microsoft Office, mainly Excel and Word and DotCompliance for documentation
What Will Convince Us
* BSc in Engineering or Life Science and/or
* Strong experience in manufacturing or quality assurance/control department within the pharmaceutical or biotechnology industry
* Experience with following GMP, FDA, ISO regulations
* Ability to work as part of a team and has a positive attitude towards internal and external stakeholders
* Strong attention to detail and problem – solving abilities
* Good communication and written skills
* Experience with MS Office, especially Excel and Word
In order to commence working with us, the successful candidate will have the right to work in the UK.
What We Offer
As a growing global life science company, stock listed on the German TecDAX, Sartorius offers a wide range of benefits:
* Making an impact right from the start: Comprehensive onboarding, including a virtual online platform – even before joining
* Welcoming Culture: Mutual support, team-spirit and international collaboration; communities on numerous topics such as coaching, agile working and businesswomen network
* Health & Well-Being: Wide section of health and well-being support such as healthcare plans and health assessment services
Benefits
Attractive Working Conditions:
* 35 hours working week
* 25 days annual leave, plus public holidays
* Free parking on site, easily accessible from the city centre and transport hubs
* Social Committee – with both free and subsidised social events
* Private Healthcare
* Pension Scheme
* Free onsite fitness classes
* Group Life Assurance
* Group Income Protection
* Free annual flu vaccinations
* Employee Assistance Programme for colleagues and their families
* One day per year given to be a 'Helping Heart' within your local community
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.