Description
Kelly Science & Clinical has an immediate opening for a Validation Manager for our growing client near Minneapolis, MN
Full-time
Direct Hire
Salary: $100,000-$130,000
Position Summary
We're seeking an experienced and motivated Validation Manager to lead and enhance our validation programs focusing on Over-the-Counter (OTC) products such as sunscreens and skincare formulations. If you have a strong technical background in the pharmaceutical or personal care industry and a passion for ensuring the highest quality standards, this is the opportunity for you! You will work closely with cross-functional teams including Quality Assurance, Quality Control, and Production to drive the success of new and ongoing validation projects.
Key Responsibilities
- Lead Validation Strategy: Own and continuously improve the development, execution, and maintenance of site-wide validation master plans.
- Qualification & Validation Expertise: Manage the entire lifecycle of validation activities, including Facility, Utility, Equipment, and Process Performance Qualifications, as well as Cleaning and Computer System Validation programs.
- Collaboration & Support: Partner with Process Engineering, Production, and Quality teams to facilitate process trials, validation runs, and pilot batches for new formulations.
- Compliance Leadership: Ensure all validation activities meet or exceed FDA regulations, OTC monograph requirements, and internal quality standards.
- Project Management Excellence: Spearhead multiple, high-impact validation projects from start to finish, ensuring timely and efficient delivery.
- Continuous Improvement: Lead risk assessments, audits, and corrective actions to drive process improvements.
- Training & Development: Develop and update SOPs, providing essential training to ensure the highest standards of quality are maintained across teams.
- Technical Support: Assist in the selection, installation, and qualification of manufacturing equipment, as well as the creation of essential documentation like batch records.
What We're Looking For
- Industry Experience: A deep understanding of pharmaceutical or personal care validation, with at least 10 years of experience, including 5+ years in OTC or Rx manufacturing.
- Regulatory Expertise: Strong knowledge of cGMP, FDA regulations, and OTC compliance standards.
- Validation Expertise: Proven track record in developing and executing robust validation systems across multiple domains, including equipment, processes, cleaning, and computer systems.
- Project Leadership: Strong project management skills with the ability to lead complex initiatives while maintaining quality and timeliness.
- Technical and Communication Skills: Excellent written, verbal, and interpersonal communication skills with the ability to communicate across all levels of the organization, including senior leadership.
- Detail-Oriented: Exceptional attention to detail, strong organizational skills, and a high level of accuracy.
- Problem-Solving & Innovation: Critical thinking, initiative, and a proactive approach to identifying and solving challenges.
- Cross-Functional Collaboration: Ability to work seamlessly with diverse teams and influence others to achieve shared goals.
- Adaptability: Able to thrive in a fast-paced environment with changing priorities.
Preferred Qualifications
- Master's degree in Chemistry, Life Sciences, or a related field.
- Lean Six Sigma certification (Green Belt or higher).
Additional Information
We are proud to be an equal-opportunity employer. Providing equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any kind.
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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