Validation Scientist

Validation Scientist - Eagan, MNThe 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 andor 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 HireMon - Friday first shift role$70,000 - $90,000yearComprehensive Benefits: Health, Dental, Vision, Short- and Long-Term Disability, Life Insurance, Paid Time Off, sick and parental leave, 401(k), etc.

Created: 2025-02-21