What are the responsibilities and job description for the Validation Engineering Specialist position at Bell International Lab?
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.
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).
Required Skills/Abilities
- 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.
Required Education and Experience
- 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 Education and Experience
- Lean Six Sigma certification (Green Belt or higher) is a plus.
Job Type: Full-time
Pay: $67,000.00 - $90,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Professional development assistance
- Referral program
- Tuition reimbursement
- Vision insurance
Application Question(s):
- Will you now or in the future require immigration sponsorship for employment authorization (e.g. H1-B or other employment-based immigration)?
Ability to Commute:
- Saint Paul, MN 55121 (Required)
Work Location: In person
Salary : $67,000 - $90,000