Validation Engineering Specialist

Bell International Laboratories, Inc•Eagan, MN

20h

About The Position

Position Summary: The Validation Engineering Specialist is responsible for the execution of qualification and validation activities at Bell International Laboratories, with a focus on Over-the-Counter (OTC) products, including sunscreens and skincare formulations. The role requires a strong technical and quality background in the pharmaceutical and/or personal care industry. The successful candidate will work cross-functionally with Quality Assurance, Quality Control, and Production teams to support new and ongoing validation initiatives.

Requirements

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.

Nice To Haves

Lean Six Sigma Certification (Green Belt or higher) is a plus.

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).