Overview
Validation Manager Jobs in Minneapolis, Minnesota, USA at Kelly Science, Engineering, Technology & Telecom
Kelly Science & Clinical is seeking a Validation Manager for a growing company located in Minneapolis, MN.
Shift: Monday-Friday 8am-5pm
Employment Type: Full Time;
Direct Hire
Summary:
As the Validation Manager, you will be responsible for the development, execution, and maintenance of all qualification and validation activities with a focus on Over-the-Counter (OTC) Products, including sunscreens and skincare formulations.
Job
Duties include:
Develop and maintain the validation master plans for the site
Develop and execute Facility, Utility, and Equipment Qualifications
Develop, execute, and maintain a robust Cleaning Validation program
Develop, update, maintain SOPs and provide training as appropriate
Aid Process Engineering, Quality Assurance, Production, and other SMEs in the development and execution of pFMEAs
Aid other departments in process trials, validation runs, and pilot batches to establish reliable manufacturing processes for new formulations
Lead and manage multiple validation projects simultaneously, ensuring on-time completion
Prepare and present technical reports, project updates, and validation metrics to senior management
Ensure qualification and validation processes comply with regulatory requirements (e.g., FDA, OTC monographs) and internal quality standards
Support quality assurance initiatives by conducting risk assessments, participating in audits, and implementing corrective actions as necessary
Provide technical support for the selection, installation, and qualification of manufacturing equipment and for the development process related documentation (i.e. batch records)
Qualifications:
Education:
Bachelor’s degree in chemistry or a related scientific field; a Master’s degree is preferred.
Experience:
10+ years in pharmaceutical and/or personal care validation.
At least 5 years in Rx or OTC manufacturing.
Knowledge:
Facility, Utility, and Equipment Qualification.
Process Performance Qualification and Process Validation requirements.
Computer System Qualification requirements.
cGMP, FDA regulations, and OTC compliance standards.
Certifications: Lean Six Sigma Certification is a plus.
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Science
Industries: Personal Care Product Manufacturing
#J-18808-Ljbffr
Title: Validation Manager
Company: Kelly Science, Engineering, Technology & Telecom
Location: Minneapolis, Minnesota, USA
Category: Engineering (Quality Engineering, Pharma Engineer), Quality Assurance – QA/QC (Quality Engineering)
