Validation Manager

A manufacturing client in Eagan, Minnesota is looking to hire a Validation Manager! This person will report to their Director of Operations and ideally should have experience in the over the counter drug or personal care space. This person will be responsible for overseeing the development, execution, and ongoing maintenance of all qualification and validation activities, with a focus on Over-the-Counter products such as sunscreens and skincare formulations. The ideal candidate will bring a solid technical foundation and quality expertise in the pharmaceutical or personal care industry. This role involves working cross-functionally with teams in Quality Assurance, Quality Control, and Production to drive both new and ongoing validation initiatives.

Responsibilities Of Position:

• Develop and maintain the site's comprehensive validation master plans.
• Lead the development and execution of Facility, Utility, and Equipment Qualifications.
• Oversee the execution of Performance Qualifications and Process Validations.
• Establish and maintain a robust Cleaning Validation program.
• Lead the creation and execution of a Computer System Validation program.
• Create, update, and maintain SOPs, offering training where necessary.
• Support Process Engineering, Quality Assurance, Production, and other subject matter experts (SMEs) in developing and executing process FMEAs.
• Assist in process trials, validation runs, and pilot batches to establish reliable manufacturing processes for new formulations.
• Lead and manage multiple validation projects, ensuring timely completion.
• Prepare and deliver technical reports, project updates, and validation metrics to senior management.
• Ensure that all qualification and validation activities meet regulatory standards (e.g., FDA, OTC monographs) and internal quality protocols.
• Participate in audits, conduct risk assessments, and support the implementation of corrective actions as needed.
• Provide technical guidance for selecting, installing, and qualifying manufacturing equipment, while supporting related process documentation (e.g., batch records).

What We Are Looking For:

• Bachelor’s degree in chemistry, physical sciences, or a related field.
• Around 10 years of experience in pharmaceutical or personal care validation
• Around 5 years in Rx or OTC manufacturing would be ideal
• Demonstrated experience in developing, executing, and maintaining validation systems.
• Strong working knowledge of cGMP, FDA regulations, and OTC compliance standards.
• In-depth knowledge of the pharmaceutical or personal care industries.
• Expertise in risk assessment practices and qualification/validation standards.
• Strong understanding of Facility, Utility, and Equipment Qualification processes.
• Comprehensive knowledge of Process Performance Qualification and Process Validation procedures.
• Expertise in Computer System Validation and Cleaning Validation protocols.
• Proven leadership experience and ability to work effectively across departments, including senior leadership.
• Strong organizational skills and ability to prioritize tasks in a fast-paced environment.
• Master’s Degree and Lean Six Sigma (Green Belt or higher) would be ideal

Salary: $100,000 - $130,000 or so, depending on experience and education, plus performance-based bonuses.