What are the responsibilities and job description for the Validation Manager position at Kelly Science, Engineering, Technology & Telecom?
Kelly Science & Clinical is seeking a Validation Manager for a growing company located in Minneapolis, MN.
Salary : $100,000-130,000 / year
Shift : Monday-Friday 8am-5pm
Employment Type : Full Time; Direct Hire
Summary :
As the Validation Manager, you will 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 :
Experience :
Knowledge :
Certifications : Lean Six Sigma Certification is a plus.
Salary : $100,000 - $130,000
