What are the responsibilities and job description for the VALIDATION MANAGER position at Cypress HCM?
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 :
Salary : $100,000 - $130,000 or so, depending on experience and education, plus performance-based bonuses.
Salary : $100,000 - $130,000
