Validation Scientist – Eagan, MN

The Validation Scientist is tasked with carrying out qualification and validation activities for Over-the-Counter (OTC) products, such as sunscreens and skincare products. This role demands a robust technical and quality expertise in the pharmaceutical and/or personal care industry. The ideal candidate will collaborate with Quality Assurance, Quality Control, and Production teams to support both new and ongoing validation efforts.

Responsibilities:

Responsibilities will include functions including Project Management, Validations, Qualifications, Quality Compliance, along with Facility and Equipment Support.

• Perform Facility, Utility, and Equipment Qualifications.
• Carry out Performance Qualifications and Process Validations.
• Execute Cleaning Validations.
• Implement Computer System Validations.
• Develop, update, and maintain SOPs and conduct relevant training sessions.
• Assist Process Engineering, Quality Assurance, Production, and other experts with pFMEAs.
• Support process trials, validation runs, and pilot batches to create reliable manufacturing processes for new formulations.
• Manage and complete assigned validation projects on time.
• Prepare and present technical reports, project updates, and validation metrics to senior management.
• Ensure that qualification and validation processes meet regulatory requirements (e.g., FDA, OTC monographs) and internal quality standards.
• Aid quality assurance by conducting risk assessments, participating in audits, and implementing corrective actions when necessary.
• Provide technical support for selecting, installing, and qualifying manufacturing equipment, and develop related process documentation such as batch records.

Requirements:

• Bachelor’s degree in chemistry, physical science, or a related field.
• At least 5 years of experience in pharmaceutical or personal care validation, including a minimum of 2 years in Rx or OTC manufacturing.
• Proven expertise in developing, executing, and maintaining validation systems.
• Strong understanding of cGMP, FDA regulations, and OTC compliance standards.
• Familiarity with the pharmaceutical industry and best practices for risk assessment.
• Knowledge of Facility, Utility, and Equipment Qualification requirements.
• Understanding of Process Performance Qualification and Process Validation requirements.
• Knowledge of Computer System Validation and Cleaning Validation requirements.
• Strong record-keeping and communication skills; ability to work cross-functionally and with senior leadership.
• Lean Six Sigma certification (Green Belt or higher) is a plus.
• Project management skills with the ability to prioritize multiple responsibilities and manage deadlines.
• Excellent written, verbal, and interpersonal communication skills.
• Proficiency with Microsoft Office.
• Ability to lift up to 20 pounds regularly.
• Capacity to wear Personal Protective Equipment, including a respirator, gloves, and eye protection.
• Ability to work in a manufacturing environment with exposure to occupational hazards.

Details:

• Direct Hire
• Mon – Friday first shift role
• $70,000 - $90,000/year
• Comprehensive Benefits: Health, Dental, Vision, Short- and Long-Term Disability, Life Insurance, Paid Time Off, sick and parental leave, 401(k), etc.