Summary of Major Responsibilities
The Validation Associate II 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 and 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.
- 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.