Validation Specialist

The Role:

Reporting to the Quality Services Lead you will coordinate and execute activities to satisfy a broad scope of validation needs, including process and cleaning validations of new systems and remediation or re-validation of existing systems. You will also support the other validation team needs including site equipment compliance with cGMP, 21CFR11, and the maintenance program within Quality Services.

At Kao, we offer amazing benefits that are available to you on your first day of employment (healthcare, 401(k) plus company match), 36 total days off (vacation and holidays and sick) and a reasonable salary range of $65,000 - $85,000. We also offer a hybrid work schedule.

What you will do:

• Execution of Validation/revalidation activities and related documentation - Scheduling, Planning and review of validation activities.
• Authoring of Documentation: including but not limited to validation plans and reports, requirements and design specifications, risk assessments, test plans and summary reports.
• Manage all facets of assigned validation projects while maintaining communication with inter departments on project status and assistance needed.
• Write and revise SOPs, WIs, and Methods for calibration, maintenance (planned and unplanned), qualification, and validation of equipment.
• Support Quality Management (QM), Plant Services, and Quality Services (QS) in design, manufacture, evaluation, and calibration of measurement standards and test systems to ensure selection of equipment that meets requirements.
• Supports the coordination and management of routine calibration and maintenance (planned and unplanned) of equipment.

What you will do:

• Bachelor of Science degree, in engineering, science or relevant technical area.
• 5+ years of experience in regulatory industry with validation profile. Knowledge of FDA compliance regulations applicable to Equipment, Process, and Cleaning Validation.
• Experience in OTC manufacturing or testing.
• Knowledge of FDA qualification and validation guidelines for equipment
• Understanding and adherence of Good Documentation Practices and current Good Manufacturing Practices
• Knowledge of computer systems and software such as SAP (PLM, QM), Empower/Chromeleon, and Microsoft Office

What we offer: A friendly and flexible work environment with great compensation packages, benefits package, ongoing development and the opportunity to enhance your skills and deliver tangible results. At Kao your voice will be heard. Your opinion really counts. We believe that change comes from taking opportunities into your own hands, so we value and reward thinking and new ideas.

Hiring Process: Kao embraces the diversity and the individual personalities of its people because we believe it is diversity that makes us strong. This is why we welcome applications from all areas of the global community.

Want to learn more: If you feel you are as unique as our products and want to find out why 33,000 people across the globe opted for a career with us please visit our Americas website (https://www.kao.com/americas/en/).

Kao USA is an equal opportunity employer, including disability/vets.

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