Validation Associate III

Abbott; Madison (WI); On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott is seeking a Validation Associate III in Madison, WI to lead and support validation activities across processes, equipment, and test methods. You will author and execute validation protocols, generate summary reports, and maintain compliant documentation in a GMP environment.

The role requires a life sciences degree (or equivalent) with 3+ years of validation experience, plus strong molecular biology skills and proficiency with MS Office.

Qualifications

• Bachelor’s or Associate degree in life sciences or related field.
• 3+ years of validation experience in a relevant manufacturing setting.
• Demonstrated proficiency in molecular biology techniques.
• Basic knowledge of statistical and mathematical methods in biology/genetics.
• Basic knowledge using software applications including Microsoft Office.

Responsibilities

• Author validation plans, validation protocols, and validation summary reports for computer systems, processes, equipment, test methods, and cleaning processes.
• Execute validation or qualification protocols, including equipment, facilities, cleaning, and/or process and test method validations as needed.
• Prepare executed validation binders, including identification of attachments and supporting data.
• Review and approve documents (protocols and reports) prepared by other team members; assist operators in validation execution.
• Follow procedures with minimal direction and maintain high documentation standards in a GMP environment.
• Collaborate effectively in cross-functional teams and communicate clearly with stakeholders.

Skills

Molecular biology techniques

Statistical methods

Documentation

Team collaboration

Communication

Education

Bachelor’s degree in life sciences or related field

Associate’s degree in life sciences or related field

Tools

Microsoft Office

MS Excel

MS Word

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 115,000 colleagues serve people in more than 160 countries.

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

We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges. Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to life’s critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions.

Position Overview

The Validation Associate III will participate or lead a variety of validation functions including protocol generation, validation execution, and summary report generation. This role will support project teams during the design transfer process and continuous improvements projects as well as supporting the maintenance of the validated state of existing equipment, processes, and methods.

Essential Duties

• Author validation plans, validation protocols, and validation summary reports for computer system, processes, equipment, test methods, and cleaning processes.
• Execute validation or qualification protocols, including equipment, facilities, cleaning, and/or process and test method validations as needed.
• Prepare executed validation binders, including identification of attachments and supporting data.
• Serve as reviewer or approver for documents (protocols and summary reports) prepared by other team members.Assist operators in understanding and documenting validation execution by being present during validation execution activities performed by other groups.
• Able to accurately follow procedures or perform work with minimal direction.
• Strong documentation skills and attention-to-detail necessary in a GMP environment.
• Able to work effectively in team situations as well as independently.
• Excellent oral and written communication and interpersonal skills.
• Participates in process FMEA risk assessments.
• May take a lead role in validation projects working cross-functionally with other departments.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 50% of a typical working day.
• Ability to work seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% of a typical working day.
• Ability to lift up to 40 pounds for approximately 10% of a typical working day.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability and means to travel 10% between local Exact Sciences Madison locations.

Required Qualifications

• Bachelor’s degree in life sciences or related field or an Associate’s degree in life sciences or related field and 2+ years of experience in lieu of a Bachelor’s degree.
• 3+ years of validation experience in a relevant manufacturing setting.
• Demonstrated proficiency in molecular biology techniques.
• Basic knowledge of statistical and mathematical methods in biology/genetics.
• Basic knowledge using software applications including Microsoft Office.
• Ability to utilize MS-Excel or MS-Word to perform basic calculations, tabulate data and prepare data.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• Experience in a biotech manufacturing environment, preferably in a GMP and/or ISO 13485 environment.

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

https ://abbottbenefits.com/

The base pay for this position is $61,300.00 – $122,700.00. In specific locations, the pay range may vary from the range posted.