Associate Validation Scientist (Eau Claire, WI, US, 54703)

Biopharma Careers; Eau Claire (WI); On-site; USD 75,000 - 120,000; Full time

Job summary

Perrigo is seeking a Validation Scientist to prepare and maintain validation protocols and SOPs for Infant Formula operations. Duties include development, execution, documentation, and monitoring manufacturing validation projects, investigate processes, and coordinate with QA, Production, Technical, and Engineering to document results of validation projects.

Responsibilities also cover annual CCP/OPRP testing, cleaning verifications, and overseeing validation master plans, ensuring compliance

Qualifications

• Bachelor's degree in engineering, chemistry, microbiology, or related field.
• 3–5 years of validation or quality experience in regulated environments.
• Experience with FDA/regulated industry standards and quality systems.

Responsibilities

• Prepare and maintain validation protocols and SOPs for infant formula operations.
• Develop, execute, document, and monitor validation projects; coordinate with QA, Production, Technical, and Engineering.
• Perform annual CCP and OPRP testing; oversee validation master plans and corrective actions.
• Support HACCP studies and ensure compliance with quality and regulatory standards.

Skills

Leadership

Communication

Technical writing

Independent work

MS Office

Data collection

Production processes

Problem solving

Education

Bachelor's Degree

Tools

Access

Excel

Word

PowerPoint

Job description

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All . We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone , we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

Description Overview

Prepare and maintain validation protocols and validation standard operating procedures for Perrigo Infant Formula operations. Duties include development, execution, documentation, and monitoring manufacturing validation projects. Investigate the manufacturing and production processes and prepare corrective actions and/or revalidation studies. Coordinate with personnel from the other departments, such as Quality Assurance, Production, Technical, and Engineering to successfully execute and document the results of the validation projects or routine programs. Perform/manage annual CCP and OPRP testing as well as the annual cleaning verifications. Oversee all Computer System Validation protocol approvals and executions.

Scope of the Role

Quality Guardianship: Ensure that routine validation work and project design and commissioning integrate the relevant Perrigo standards and relevant regulatory standards. Prepare validation studies and protocols final reports, on a timely basis. Validation scope includes, but is not necessarily limited to: process vessels, cleaning/sanitization, product and process line sterilization, automated/electronic control systems, manufacturing processes. Plan and execute multiple assigned validation activities simultaneously, which may include use of PCs monitoring, laboratory work environment as well as significant projects for new lines, new products process/facility/equipment modifications or process improvements. Support HACCP study, process flow and QMS reviews. Assist in the HACCP study completion on a timely basis.

Quality Control Activities: Supports projects as Validation/Food Safety/Quality representative. Supports HACCP for the implementation and management of relevant food safety control measures. Prepare and maintain QA/Validation standard operating procedures. Develop and maintain compliance with Validation Master Plans. Follow Good Manufacturing Practices; report food safety and quality issues immediately.

People and Know-How:For validation programs, develop the required training material, train and coach on the required elements to ensure that production will take place achieving the objectives defined for food safety and quality. Drive the development of competence of operators and promote quality awareness and commitment.

Quality Auditing and Verification: Perform annual verification activities, including CIP and CCP/OPRP verifications. Support readiness for internal and external audits. Support Management of Change (MOC) as needed. Maintain compliance with regulations and refer to the Quality Management System on all related procedures and programs. Understand the food safety and quality aspects of the position.

Quality Mastership: Support Continuous Improvement initiatives in the quest for zero defect. Support activities to achieve compliance with the Quality Management System requirements and other applicable instructions and standards. Identify non-conformance issues and coordinate Quality/Food Safety risk analysis.

Performs other duties as assigned.

Experience Required

Academic Experience Required

Bachelor’s Degree in Engineering, Chemistry, Microbiology, or related field or equivalent work experience in a validation scientist role

Operational Experience

• Experience with validation responsibilities in food, pharmaceutical, or medical device field
• Minimum of 3-5 years of related Quality experience
• Experience in regulated food manufacturing environment with exposure to 21 CFR 117, lean manufacturing, FSSC22000/SQF regulations and preferred experience with 21 CFR 106/107 and 21 CFR 113.

SKILLS:

• Leadership and people development skills
• Local language and English language written and spoken
• Excellent written and oral communication skills, including report writing
• Ability to work independently and handle multiple priorities
• Proficiency with PCs and software such as Access; Excel; Word; PowerPoint;
• Technical writing ability in an FDA regulated industry and ability to translate technical / quality / compliance theory into practical application
• Demonstrated ability to lead projects and teams
• Working knowledge of production processes and equipment
• Analytical and problem solving skills
• Working knowledge of instrumentation and data collection

Benefits

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo.

We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo