HireDiversity

Jacksonville, FL, US

STAFF PROCESS ENGINEER, PAT-4424120918

Description

Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Process Engineer, Process Analytical Technology - Vision Care, to be located in Jacksonville, Florida.

Johnson & Johnson Vision Care, Inc., - VistakonŽ Division of Johnson & Johnson Vision Care, Inc., specializes in disposable contact lenses, which it markets under ACUVUEŽ Brand contact lenses. Ever since ACUVUEŽ transformed vision correction in 1988 with the world's first soft disposable contact lenses, we've passionately pursued new technologies and the highest quality standards. We're proud that ACUVUEŽ lenses are worn by more people than any other brand.

Reporting to the Sr. Manager, Process Analytical Technology, R&D Quality Assurance, the Staff Process Engineer will be a creative, hands-on engineer to establish process analytical technology capability on production and pilot platforms, and provide technical leadership to leverage this technology to define and deploy process signatures and controls strategies to drive "good" lenses for legacy and new products.

The Staff Process Engineer, Process Analytical Technology (PAT), must be a creative, hands-on engineer to establish process analytical technology capability on production and pilot platforms, and provide technical leadership to leverage this technology to define and deploy process signatures and controls strategies to drive "good" lenses for legacy and new products. This will include applying and developing advanced analytics and statistical Process Controls (SPC) for the identification of critical process parameters, and developing monitoring, and real time control strategies.

This position supports robust identification of, and development of control strategies for, critical process variables. This position will provide innovative thinking along with a disciplined approach for the rapid, compliant, and high quality development and manufacture of products across multiple plant locations while ensuring business and regulatory requirements are achieved. This position provides leadership on Vistakon process capability.

This position will collaborate closely with business partners in R&D, Quality, FOD, MAKE, and Regulatory teams in problem solving and experimental strategy to define and manage PAT process capability improvement efforts on legacy and new products. The Staff PAT Process Engineer will assist in identifying improvement projects and ensuring project initiatives align with business objectives. This position writes, reviews and critiques developmental protocols and completion reports. They conduct, review and critique data analysis and recommendations from testing and development protocols. They also collaborate with internal functions and suppliers to finalize product and process requirements. This position participates in decision making and makes recommendations to management with regard to short term and long terms program objectives.

Candidates will actively participate in Quality Function Deployment, design and process FMEA's, project plan development, updates to management board & other core team activities to help establish project direction and ensure total team success. This position is responsible for adhering to environmental and safety policy and procedures and supports department environmental and safety objectives.

Plans, coordinates, and enables Process Analytical Technology projects designed to establish or refine Critical to Quality (CTQ) product and process requirements, monitoring and control strategies, to support proactive quality and consistent, high product quality. Ensures activities are aligned with established company and regulatory standards by performing duties. Writes and reviews report findings and makes recommendations for/implements corrective action.Prepare and present communications, status updates and metrics for team and senior management. Participates in J&J and MD&D sector initiatives and other related duties as assigned by management. Supports internal and external audits when called upon (including FDA and ISO).

Qualifications


This position requires a minimum of a BS in Engineering or relevant engineering discipline with a minimum of 6 years experience working in industry. Advanced degree preferred . Process engineering experience required. Experience in a regulated industry such as medical device, consumer product, semi conductor, automotive, aerospace or pharmaceutical industry preferred. Demonstrated experience in new product process development is required.
Candidates with a thorough working knowledge of the validation requirements for Medical Devices, Pharmaceuticals and/or Biologics with demonstrated experience is preferred.

Experience in a high volume, high speed, and high precision manufacturing environment is a plus for this position.

Demonstrated ability to select and apply appropriate statistical tools for problem solving during the process development process is required. Working knowledge of Six Sigma/Process Excellence Tools (DMAIIC, DMADV, or Lean) which include Design of Experiments and capability analysis is required. Black Belt Certification is preferred. Candidates who have experience using MiniTab or SAS/JMP are required.

Proven good judgment and decision making with a bias for action in a fast paced working environment required. Must drive for excellence, yet maintain understanding and risk balance approach. Must have high integrity, work well within cross-functional teams, and confidently express opinions and challenge status quo thinking. Strong communication skills; making complex issues easy for others to understand and the ability to prepare communications for team and senior management. Experience in leading technical teams and influencing is required.

Proficiency with Microsoft Office. Experience in the development and execution of project plans, including time, budget, and program management skills preferred.

Must be able to travel up to 20% both domestic and international. This position will be based in Jacksonville, FL.

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)