Job Title:Senior Validation Engineer
When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of more than $24 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
As a Senior Validation Engineer, you will be working with several departments to provide validation support. You will be working on the validation of computer systems, equipment and equipment systems, along with the critical utilities and facilities required for operations at both our Horsham & Crawley sites. You will ensure site compliance and that all necessary maintenance activities are performed on time so that all Engineering & Facilities validated systems are kept in a validated state.
In this role you will report directly into the Site Technology, Innovation & Investment Lead, but you will also work with the Engineering & Facilities Director, in order to build the validation capability within the team.
The role will be based at our site in Horsham, which is primarily used for work related to Clinical Trials. The business functions onsite include, Operations, Facilities, Customer Support, Sales, Finance, IT, Storage and Distribution, and it is the base for circa 550 of our employees.
The Horsham site has received continued investment in order to maintain security of supply to our customers and also to enable business growth opportunities.
What you do will include:
Providing expert subject matter support on Validation & CSV related issues.
Lead and further develop the Engineering Validation departmental capability in conjunction with the Director of Engineering & Facilities
Support validation / qualification activities
Plan and formulate validation aspects of engineering projects
Author SOPs related to validation/re-validation activities
Represent Engineering validation in cross-functional meetings/projects
Author, execute, perform, and summarise qualification and validation activities including URS, SIA, QP, DQ, IQ, OQ, PQ, CSV & QSR.
Maintain FCS validation methodology
Perform risk assessment and mitigation
Work closely with engineering to coordinate and execute Factory Acceptance Testing (FAT) & Site Acceptance Testing (SAT) activities and protocols.
Responsible for the completion of change control activities relating to qualification/validation of equipment, facilities, systems, CSV, documentation and databases
Conduct root cause analysis and deviation resolution for validation exceptions
Who we are looking for:
A documented FBS expert in Equipment Validation and Computer Systems Validation (CSV)
Good experience of validation/CSV in a Good Manufacturing Practice (GMP) environment – preferably with pharmaceutical experience, but this is not essential
Knowledge of GMP legislation
Previous experience working with temperature mapping software
Experience in dealing with Local and Regulatory Authorities
Excellent presentational & motivational skills
Ability to establish effective working relationships and an effective communicator
Degree in Engineering or a Scientific discipline
What’s in it for you:
Competitive base salary
Free on-site car parking
A competitive contributory pension
Private medical insurance
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 75,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
With Thermo Fisher Scientific, it’s not just a career. It’s a chance to realise your best – professionally and personally.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.