Business Job Title: Senior Validation Engineer- CSV
Position Location: Horsham
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. 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 responsible to interact with several departments to provide validation support to validate computer systems, equipment and equipment systems, along with the critical utilities and facilities required for operations at the Horsham & Crawley Sites. You will be responsible to ensure site compliance and all necessary activities are performed on time to keep all Engineering & Facilities validated systems in a validated state.
Plan and formulate validation aspects of engineering projects including; development and plan Design of Experiments, supporting Proof of Principle work on new products/processes and execution of Engineering studies.
Author, execute, perform, and summarize qualification and validation activities inc. URS, SIA, QP, DQ, IQ, OQ, PQ, CSV & QSR.
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
Provide expert subject matter support on Validation & CSV related issues.
Lead and further develop the Engineering Validation departmental capability in conjunction with Director, Engineering & Facilities
To support validation / qualification activities including equipment, facilities (inc. temperature mapping), systems, EMS, CSV and temperature controlled shippers.
Maintain FCS validation methodology in accordance with applicable Quality/Regulatory requirements and industry best practices.
Perform risk assessment and mitigation supporting the attainment and maintenance of a validated state of compliance for all equipment, processes, materials, and facilities.
Perform technical reviews and interpret data for accuracy of equipment/process performance for completed validations/revalidations.
Author SOPs related to validation/revalidation activities
Ensure and/or execute proper calibration and maintenance of test equipment used for validation/revalidation and temperature mapping of equipment, processes and facilities.
Assist with identification and execution of master validation plan (MVP) as required
Conduct root cause analysis and deviation resolution for validation exceptions
How will you get here?
Bachelor Degree in Engineering or Scientific discipline
Minimum of 3 years validation experience in a GmP environment- essential
Is a documented FBS expert in Equipment Validation and Computer Systems Validation
Relevant Pharmaceutical/GmP Industry experience - essential
Previous experience in validation/CSV role- essential
Knowledge of GmP legislation
Experience in dealing with Local and Regulatory Authorities
Excellent presentation & motivational skills
Ability to establish effective working relationships and effective communicator
Previous experience working with temperature mapping software.
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 unrivaled 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. For more information, please visit www.thermofisher.com.
Thermo Fisher Scientific is an Equal Opportunities Employer and does not discriminate on the basis of race, colour, religion, sexual orientation, gender identity, national origin, disability or any other legally protected status.