Validation Engineer

Abbott; Des Plaines (IL); On-site; USD 60,000 - 120,000; Full time

Job summary

An established industry player is seeking a Validation Engineer to join their dynamic team in Des Plaines, IL. In this pivotal role, you will be responsible for preparing and executing validation protocols, ensuring compliance with international standards, and enhancing engineering solutions for manufacturing processes. This position offers the chance to work with cutting-edge technologies in the healthcare sector, providing a meaningful impact on patient outcomes. With a strong emphasis on career development and a supportive work environment, this opportunity is perfect for those looking to grow in their engineering career while contributing to life-changing innovations.

Benefits

Free medical coverage

Retirement savings plan

Tuition reimbursement

Student debt program

Education benefits

Qualifications

• 3+ years of engineering experience in a manufacturing environment.
• Knowledge of cGMPs and regulatory filings for medical devices.

Responsibilities

• Validate automated manufacturing equipment and facilities.
• Execute process development activities and document via ELN.
• Own CAPA related actions and execute investigations.

Skills

Six Sigma

Process Validation

Risk Analysis

Quality Systems

Teamwork

Communication Skills

Education

Bachelor's degree in Chemical/Biochemical Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Polymer Sciences/Engineering

Tools

Electronic Lab Notebook

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Job Title

Validation Engineer

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

Process Engineer - Des Plaines, IL

The Validation Engineer will be primarily involved in preparing, drafting, and executing validation protocols. They ensure that the assigned validation areas are effectively managed and all elements follow the requirements specified by Abbott Molecular Diagnostics Division Quality System and relevant international standards. This individual will also participate in the development and improvement of engineering solutions for equipment, processes, parts, and components.

What You’ll Work On

Equipment Validation:

• Validate automated manufacturing equipment, ancillary equipment, facilities, and utilities.
• Draft Validation Change Requests and align on validation requirements with CFT members.
• Draft and approve validation protocols for IQ/OQ/PQ/PV activities.
• Execute validation tests, record data, and draft and approve validation reports.
• Draft and execute engineering studies to characterize processes as part of validation efforts.

Process Development:

• Execute process development activities as part of characterization studies to support validations.
• Document activities via Electronic Lab Notebook entries.
• Create and execute Designed Experiments, Gage R&R studies, Measurement Systems Analyses, and Test Method Validations.

Compliance Support:

• Execute studies, test methods, and engineering activities as part of CAPA and Non-Conformance investigations and actions.
• Own CAPA related actions and action plans.
• Execute investigations and document via CAPA electronic system.

Required Qualifications

• Bachelor's degree (BS) in Chemical/Biochemical Engineering, Biomedical Engineering, Polymer Sciences/Engineering, or Science.
• Minimum of 3 years of engineering experience in a manufacturing environment.
• Process/equipment development and optimization experience in in-vitro diagnostics, small volume filling, and assembly/packaging of plastic components.
• Knowledge of late-stage or commercial products with a strong focus on manufacturing support.
• Experience with Six Sigma, risk analysis methodologies, process characterization, process validation, and process monitoring, scale-up, and/or technology transfer, PFMECA, DFMECA.
• Strong knowledge of Quality systems, med device manufacturing, and process validation.
• Work history with cGMPs, regulatory filings, and compliance issues for med device products and combination devices.
• Excellent organizational, leadership, teamwork, written and verbal communication skills, with demonstrated ability to work in a highly matrixed team environment with enthusiasm and a proactive positive attitude.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted.