HireDiversity

Jacksonville, FL, US

Senior Validation Engineer, Facilities-4939120504

Description

VISTAKONŽ, a division of Johnson & Johnson Vision Care, is recruiting for a Senior Validation Engineer, Facilities, to be located in Jacksonville, Florida.

VISTAKONŽ, a division of Johnson & Johnson Vision Care, is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe / Middle East / Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, no other manufacturer has matched the aggressive expansion of our wide-ranging ACUVUEŽ family of products. Our associates around the world are committed to expanding the ACUVUEŽ brand, and fortifying our position as the worldwide leader in the contact lens industry.

The Senior Validation Engineer, Facilities, manages facilities validation activity to ensure work is being completed to support production output. This individual is responsible for Commissioning and Qualification of critical utilities including but not limited to: DI Water, Nitrogen, Compressed Air and HVAC. Responsible for Commissioning and Qualification of equipment and qualification of laboratory equipment. Responsible for Commissioning and Qualification documentation generation, review and approval, where appropriate including: Validation Project Plans, FMEAs/Risk Assessments, Functional Design Specification, Factory Acceptance testing, Site Acceptance Testing, IQ, OQ and PQ protocols and reports, Investigations, Commissioning Test Plans, and User Requirement Specification.

The Senior Validation Engineer, Facilities, reviews computer system validation documentation for upgrade to laboratory equipment software and utility PLCs. Leads validation projects by developing and delivering on the strategy related to the qualification of facility, utilities, process equipment and associated computer systems associated. Adheres to environmental and safety policies and procedures and supports the department's safety and environmental objectives.

This individual leads/manages facilities validation activities/projects. This includes the overall planning of the department's validation projects. Creates, reviews and/or approves software, equipment, and product/process qualification documentation. Performs other related duties as assigned by management.

Qualifications


A Bachelor's degree and at least 4 years of professional work experience is required. Professional work experience MUST be in Process or Quality Engineering / Test Development / Validation within a regulated industry. Microbiology and/or Chemistry experience is preferred. Excellent understanding and application of principles, concepts and practices of statistical methods, validation methods, and QSR/ISO regulations is required. Excellent communication, interpersonal, conflict management and organization skills are required. Strong leadership and coaching skills are required. Proficiency in the Microsoft Office suite of products is required. LIMS (Laboratory Information Management Systems) experience is preferred. This position will be located in Jacksonville, Florida.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Florida-Jacksonville
Organization: Johnson & Johnson Vision Care, Inc. (6094)