Bell International Laboratories ยท 1 day ago
Validation Specialist
Eagan, MN
Full-time
Onsite
Mid Level
$67K/yr - $90K/yr
3+ years expBell International Laboratories is focused on Over-the-Counter (OTC) products and is seeking a Validation Engineering Specialist. The role involves executing qualification and validation activities while collaborating with various teams to support validation initiatives and ensure compliance with regulatory requirements.
BeautyCosmeticsManufacturing
Hiring Manager
Natasa Saremi, MA
Responsibilities
Perform Facility, Utility, and Equipment Qualifications
Assist in executing Performance Qualifications and Process Validations
Support the implementation and documentation of Cleaning Validation activities
Conduct Computer System Validations
Assist with updating SOPs and participate in training sessions as needed
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
Execute validation projects as assigned, 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)
Qualification
Required
Background in the pharmaceutical industry
Familiarity with industry best practices for risk assessment
Knowledge of Facility, Utility and Equipment Qualification requirements
Understanding of Process Performance Qualification and Process Validation requirements
Working knowledge of Computer System Validation Requirements
Working knowledge of Cleaning Validation Requirements
Strong technical and/or regulatory expertise
Detailed record keeping and communication of results to others
Project skills appropriate for leadership of validation projects
Excellent written, verbal, and interpersonal communication skills
High level of initiative, innovation, critical thinking, and problem-solving skills
Ability to work cross-functionally & at all levels within the organization including senior leadership
Ability to prioritize multiple responsibilities and manage deadlines accordingly
Communicate effectively and professionally both internally and externally
Exceptional attention to detail and high level of accuracy & organization
Ability to work as part of a team and excel independently in fast-paced environment
Ability to adapt quickly to changing circumstances
Demonstrated leadership skills
Proficient with Microsoft Office
Bachelor's degree in chemistry or other physical science or a related field
Minimum of 3+ years of experience in pharmaceutical and/or personal care validation, with at least 1 year in Rx or OTC manufacturing
Demonstrated expertise in the development, execution, and maintenance of validation systems
Strong knowledge of cGMP, FDA regulations, and OTC compliance standards
Preferred
Lean Six Sigma Certification (Green Belt or higher) is a plus
Company
Bell International Laboratories
Bell International Laboratories is a manufacturer of cutting edge, innovative, health, beauty, OTC, and cosmetics products
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase