Validation Engineer
Validation Engineer
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$ $ 70000 - 95000
1 Vacancy
Job Description
About the Role
The Validation Engineer is responsible for executing qualification and validation activities for OvertheCounter (OTC) products including skincare formulations and sunscreens. This position focuses on ensuring compliance with regulatory standards and internal quality requirements. The engineer will collaborate with Quality Assurance Quality Control and Production teams to support ongoing and new validation projects. A strong technical and quality background in the pharmaceutical or personal care industries is essential.
Responsibilities:
- Develop and execute Facility Utility and Equipment Qualifications.
- Conduct Performance Qualifications Process Validations and Cleaning Validations.
- Implement Computer System Validations and maintain robust validation programs.
- Update and manage Standard Operating Procedures (SOPs) and provide necessary training.
- Assist in process engineering efforts such as pFMEAs and conduct risk assessments.
- Execute assigned validation projects ensuring ontime delivery and compliance.
- Prepare and present technical reports and validation metrics to senior management.
- Provide technical support for equipment selection installation and related documentation.
Qualifications:
- Bachelors degree in chemistry engineering or a related physical science.
- At least 5 years of validation experience in the pharmaceutical or personal care industries with 2 years in OTC or Rx manufacturing.
- Strong knowledge of cGMP FDA regulations and OTC compliance standards.
- Proficiency with Microsoft Office and excellent communication skills.
- Demonstrated ability to work crossfunctionally and manage validation projects effectively.
Preferred Qualifications:
- Lean Six Sigma certification (Green Belt or higher).
- Advanced Microsoft Excel skills and experience with process improvement methodologies.
- Leadership capabilities critical thinking and problemsolving skills.
- Experience in midlevel manufacturing roles with a focus on validation systems.
- Bonus
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Employment Type
Full Time
