500 Senior Validation Engineer jobs in Durham,NC

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Process Development Engineer 1

Dell

Apex, NC

~ 27 min Onsite

Process Development Engineer 1
Supporting Global Operations Storage and Solutions manufacturing
Driving Productivity improvements with Quality focus
Work with multiple local organizations such as Operations, Quality, Test Engineering, and EH&S
Determine manufacturing cost, timing, capacity and equipment requirements
Support Manufacturing Operations to initiate process improvements to improve factory output and reduce cycle time
Works with other engineers and group teams on projects to exchange information and assist on project completion
Create/update/maintain nd provide necessary training to operators per EH&S; requirements
Estimate manufacturing cost, determine time standards and make recommendations for tooling and process requirements of new or existing product lines, including Automation
Maintain records and reporting systems

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FSP Senior Safety Specialist

Thermo Fisher Scientific

Durham, NC

Onsite

Bachelor's /Master's degree (or local equivalent) in nursing, healthcare or other life-science or relevant field
Solid experience with the end to end process of safety event collection and reporting
Relevant experience with the development and submission of aggregate safety reports (e.g. DSUR, PSUR)
Solid expertise of global (EU/US) pharmacovigilance requirements and practices
Solid experience with safety database systems (e.g. ARGUS or ArisG) including workflow management
Experience in interaction with 3rd party vendors would be a plus
Experience with the generation and evaluation of quality metrics would be a plus
Fluent communication in written and spoken English
Advanced knowledge of medical terminology, pharmacovigilance processes and relevant regulations, including global requirements (e.g. EU, US, Japan)
Ability to communicate complex issues in an understandable, effective and relevant manner
Ability to manage and prioritize a variety of tasks to meet required deadlines
Ability to solve routine problems with limited supervision and to raise issues constructively
Ability to deliver high quality documents, including work instructions, guidelines, forms and templates
Takes ownership of assigned work and manages timelines for deliverables with minimal support
Ability to make basic operational decisions with an understanding of the impact and potential risk
Advanced computer skills, including proficiency with Microsoft Office
Proficiency with safety database systems (i.e. Argus) and MedDRA coding
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
Able to work upright and stationary for typical working hours
Ability to use and learn standard office equipment and technology with proficiency
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
3- 5 years of relevant experience in global pharmacovigilance/drug safety (EU&)