Validation Engineer I/ II

2 weeks ago

Athens, United States Maxis Clinical Sciences Full time
Job DescriptionJob Description

Duties:
Perform Smoke studies and assist in semi annual Media fill qualifications as a SME Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers and warehouse areas.
Has worked with Ellabs data loggers and software Write and execute protocols and complete final reports.
Understanding of cleaning validation concepts and principles.
Understands pharma grade utilities ( water HVAC, gases) Support Maintenance, Engineering and Production Depts. in the selection, review, acquisition, and upgrade of systems and production equipment.
Provide technical support in developing user and functional requirements specifications, URS, RA, FRS, and DQ for systems and equipment.
Develops and Assists with audit responses and completion of assigned CAPAs by target due dates. Included is the responsibility for making sure Validation areas are "inspection ready " at all times.
Support Change Control, Deviation and CAPA activities

Skills:
Aseptic processing
Protocol generation
Sterilization
Validation
FDA/USDA

Education:
Bachelors , preferable in a science or engineering related field

Required Skills:
HVAC
VALIDATION ENGINEER
CGMP
FILLING LINES
BIOPHARMACEUTICAL

Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.

Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r
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Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.

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