Description
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.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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