Validation Associate III

Exact Sciences • Madison, WI

149d • $51,000 - $84,000

About The Position

At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. 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.

Requirements

• 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.

Nice To Haves

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

Responsibilities

• 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.
• Participate in process FMEA risk assessments.
• May take a lead role in validation projects working cross-functionally with other departments.
• Support and comply with the company’s Quality Management System policies and procedures.
• Maintain regular and reliable attendance.

Benefits

• Paid time off (including days for vacation, holidays, volunteering, and personal time)
• Paid leave for parents and caregivers
• Retirement savings plan
• Wellness support
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 501-1,000 employees