What are the responsibilities and job description for the Validation Engineer position at Bell International Laboratories, Inc?

Job Description

Description : Position Summary :

The Validation Engineer 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 : Responsibilities

Validation & Qualification :
Develop and execute Facility, Utility, and Equipment Qualifications.
Develop and execute Performance Qualifications and Process Validations.
Develop and execute a Cleaning Validations.
Develop and execute a Computer System Validations.
General :
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.
Project Management :
Execute validation projects as assigned, ensuring on-time completion.
Prepare and present technical reports, project updates, and validation metrics to senior management.
Compliance & Quality :
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.
Equipment & Facility Support :
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

Working knowledge or background in the pharmaceutical industry.

Working knowledge of industry best practices for risk assessment.

Working knowledge of Facility, Utility and Equipment Qualification requirements.

Working knowledge 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 5 years of experience in pharmaceutical and / or personal care validation, with at least 2 years 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.

Physical Demands

Must be able to lift up to 20 pounds on a regular basis.

Ability to wear Personal Protective Equipment including a respirator, gloves and eye protection.

Ability to perform work in a manufacturing environment where there is exposure to occupational hazards.

EEO Statement

Bell International Laboratories provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

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