Engineering Project Coordinator

2 weeks ago

Rochester, New York, United States Bausch & Lomb Full time
Company Overview:
Bausch + Lomb is a prominent global leader in eye health, committed to safeguarding and enhancing vision for millions worldwide, from infancy through all stages of life.

Mission Statement:
Our mission is straightforward yet impactful: to assist you in seeing better, thereby enabling you to live better.

We offer a comprehensive range of over 400 products, meticulously designed to cater to our customers' diverse eye health requirements throughout their lives.

Our esteemed brand is founded on the profound trust and loyalty of our customers, cultivated over our 170-year legacy.

With a robust global presence, we employ approximately 13,000 individuals and operate in nearly 100 countries, reaching billions of potential customers globally.

We have been at the forefront of numerous significant advancements in eye health and are poised to continue leading the charge in the future.


Objectives:
To successfully complete engineering projects by organizing and managing various project components to support medical device manufacturing operations and the deployment of new technologies.

Provide project management support to the Rochester site, encompassing:
new product introductions, process validations, equipment qualifications, operational enhancements, and compliance-related change control.

Key Responsibilities:


Define project objectives by developing and reviewing project proposals and plans, collaborating with plant management and other stakeholders, including Commercial, Regulatory, Medical Affairs, R&D, and Quality.

Engage in cross-functional teams with Project Management, Quality, Operations, and Engineering to fulfill business goals.
Initiate, manage, and execute Quality Change Requests (QCRs) to implement process modifications.
Act as the site project lead for new product launches and setups.

Identify project responsibilities by delineating project phases and components; collaborate with functional managers in matrix organizations to allocate personnel accordingly.

Establish project timelines by analyzing project plans and objectives, estimating time requirements, and sequencing project components.
Maintain project timelines by tracking progress, coordinating activities, and addressing issues as they arise. Escalate concerns as necessary.
Manage project expenditures by monitoring and adhering to established budgets.
Review and revise relevant procedures, specifications, and work instructions within the project's scope.
Draft and oversee the execution of testing strategies, engineering studies, equipment/process qualifications, and process validations.
Ensure project adherence to company policies and quality standards, including change control, validation, and NC/CAPA.
Exhibit a high degree of adaptability to manage a variety of tasks and projects effectively.

Qualifications:
A Bachelor's degree is required; a degree in Engineering is preferred. A Master's in Engineering or an MBA is advantageous.
5+ years of experience in Project Management or Engineering roles, demonstrating a progression of skills.
Experience in medical device manufacturing or other FDA-regulated industries is preferred.
Proven problem-solving abilities and a track record of meeting deadlines are essential.

Specialized Training:

Proficiency in Manufacturing Methods and Procedures, Process Improvement, Technical Understanding, Documentation Skills, Presentation Skills, Team Building, LEAN / Six Sigma, and Validation.

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