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Validation Scientist

Kelly Science, Engineering, Technology & Telecom
Eagan, MN Full Time
POSTED ON 2/9/2025 CLOSED ON 5/3/2025

What are the responsibilities and job description for the Validation Scientist position at Kelly Science, Engineering, Technology & Telecom?

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.
  • Salary : $70,000 - $90,000

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