Senior Engineer Validation Specialist

Baxter; Jayuya (PR); Vor Ort; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Vacation and Paid Holidays

Medical, Dental, Disability and Life

Vision and Voluntary Benefits

Paid Parental Leave

Retirement Savings Plan - 165E

Employee Stock Purchase Program

Educational Assistance Plan

Zusammenfassung

Baxter is seeking a Senior Process Engineer to lead manufacturing maintenance and process upgrade activities in a fast-paced, FDA-regulated environment. You will coordinate technical developments, resolve design and test problems, and drive compliant changes while mentoring teammates in a collaborative, quality-focused culture.

Ideal candidates hold a Bachelor’s degree in Engineering or Sciences, with 5+ years’ experience in product development, change control, and validation.

Qualifikationen

• Bachelor's degree in Engineering or Sciences; manufacturing experience required.
• Minimum 5 years experience in product development, change control, validations or related areas.

Aufgaben

• Performs, coordinates, and exercises functional authority for planning, organization, control, integration, and completion of engineering maintenance and process upgrade tasks.
• Coordinates activities concerned with technical developments, scheduling, and resolving engineering design and test problems.
• Directs integration of technical activities and products; evaluates and approves design changes and drawings.
• Ensures compliance with cGMPs, Safety and FDA regulations; creates and revises SOPs.

Kenntnisse

Project management

Problem solving

Team leadership

Communication

Adaptability

Ausbildung

Bachelor's degree in Engineering or Sciences

Jobbeschreibung

This is where your work makes a difference.

At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job-you will find purpose and pride.

Your role at Baxter

This is where your expertise helps people

You are a problem solver. Complex projects or unexpected challenges are just opportunities to bring your considerable abilities to use. Whether working independently or with a trusted team, you are always ready to tackle a project and work hard to find solutions.

Your talent is needed across a wide variety of industries. As a Senior Process Engineer , you have a wide array of career choices, but are motivated by the opportunity to work in a company that supports innovation, professional development, and a purposeful mission.

Your team

We are a team of inquisitive individuals who embrace a collaborative environment to take on sophisticated challenges that meet the needs of our patients. We often need to change directions and respond to issues to avoid disruptions in our fast-paced manufacturing environment. Together, we build and maintain a positive work environment.

Our team is dedicated to quality. Delivering life-saving products is about getting them right, and our technical expertise and experience working in a manufacturing environment empower us to meet that challenge.

When you join us, you will work with a team of committed individuals who trust each other to deliver on the tasks at hand. We support innovation and out-of-the-box thinking balanced with collaboration across functions and other teams. Our leadership understands the need for continuous education and provides opportunities for further development.

As a Senior Process Engineer , you will have the opportunity to lead by example, and enjoy mentoring and learning from others. Here, you are trusted to manage your own time and are given opportunities to grow your career as you wish.

What we offer from day 1:

• Vacation and Paid Holidays
• Medical, Dental, Disability and Life Insurance coverage
• Vision and Voluntary Benefits
• Paid Parental Leave
• Retirement Savings Plan - 165E
• Employee Stock Purchase Program
• Educational Assistance Plan

What you'll be doing

• Performs, coordinates, and exercises functional authority for planning, organization, control, integration, and completion of engineering maintenance and process upgrade tasks within area of assigned responsibility. Use project management tools to achieve cost reduction results per the strategic plan on every budget process. Coordinates Plant schedule and resources within the assign manufacturing area.
• Coordinates activities concerned with technical developments, scheduling, and resolving engineering design and test problems.
• Directs integration of technical activities and products.
• Evaluates and approves design changes, specifications, and drawing releases.
• Controls expenditures within limitations of project budget.
• Prepares interim and completion project reports.
• Active participation on budget cycle updating, cost impact and QLP process.
• Assists, trouble shoots, give technical support to all assigned equipment and personnel.
• Develops, implements systems or projects, procedures and policies to assure the compliance with cGMP's, Safety and FDA regulations.
• Creates, reviews and implements changes to specifications and SOP's.
• Audits all areas under responsibility assuring the compliance, cGDP's, specifications, SOP's, and procedures.
• Supports and assists in the trouble shoot of projects and equipment as required. Also assists validations process.
• Completes all documentation and reports on a timely basis as required (daily, weekly, monthly and annually).
• Keep and develop strong working team, manufacturing maintenance environment.
• Should be able to work at any shift when its required. (eg. shutdowns, extraordinary, holidays, events).
• Good and strong supervisions skills.
• Able to work with many projects and handle multiple tasks at the same time.
• Request and order all materials required on a timely basis to ensure an efficient performance of the department.
• Must be able to communicate effectively at all Plant Levels.
• Willing to travel.

What you'll bring

Bachelor's degree in Engineering or Sciences with manufacturing experience minimum of 5 years experience in product development, change control, validations, or related areas; Master's degree or PhD with at least 1-2 years of exp