Validation Associate III

• 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

• 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

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

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