Validation Specialist - Serialization

MENTOR Technical Group Corporation; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Mentor Technical Group is seeking a meticulous Validation Engineer specializing in Serialization to ensure compliance with industry standards. The role involves developing validation protocols, conducting studies, and collaborating with teams to ensure product integrity and quality in a dynamic work environment.

Benefits

Comprehensive health, dental, and vision insurance

Opportunities for professional development and career advancement

Qualifications

• Proven experience in validation engineering, specifically in serialization.
• Strong knowledge of GMP regulations, validation protocols, and risk assessment methodologies.
• Master’s degree in Engineering or a related field preferred.

Responsibilities

• Develop and execute validation protocols for serialization equipment, processes, and systems.
• Document validation activities and results, maintaining comprehensive records.
• Collaborate with production staff and Quality Assurance for operational consistency.

Skills

Communication

Problem-solving

Attention to detail

Education

Bachelor’s degree in Engineering, Computer Science, or related field

Tools

Validation tools

Statistical analysis software

Job description

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Job Summary:We are seeking a meticulous and experienced Validation Engineer specializing in Serialization to join our team. The ideal candidate will be responsible for ensuring that serialization processes and systems meet industry standards and regulatory requirements. This role involves designing validation test methods, conducting process validation studies, preparing detailed reports, and collaborating with cross-functional teams to ensure the integrity and quality of serialized products.

Key Responsibilities:

• Develop and execute validation protocols for serialization equipment, processes, and systems.
• Document validation activities and results, maintaining comprehensive records for all validation activities.
• Analyze validation test data to determine whether systems or processes meet validation criteria.
• Ensure all serialization systems are running according to necessary specifications and comply with regulatory standards.
• Collaborate with production staff to ensure operational consistency and effectiveness.
• Coordinate with Quality Assurance and Engineering departments to ensure timely execution of validation activities.
• Investigate and resolve issues that could impact product quality and serialization integrity.
• Participate in quality audits and respond to audit findings with appropriate corrective actions.
• Stay current with industry trends and regulatory standards to ensure validation processes are up-to-date.

Required Skills and Qualifications:

• Bachelor’s degree in Engineering, Computer Science, or a related field.
• Proven experience in validation engineering, specifically in serialization.
• Strong knowledge of GMP regulations, validation protocols, and risk assessment methodologies.
• Proficiency in validation tools and statistical analysis software.
• Excellent problem-solving and decision-making skills.
• Strong communication and collaboration abilities.
• Attention to detail and a commitment to quality.

Preferred Qualifications:

• Master’s degree in Engineering or a related field.
• Certifications in validation practices or quality management systems.
• Experience with regulatory audits and compliance.

Compensation and Benefits:

• Competitive salary based on experience.
• Comprehensive benefits package including health, dental, and vision insurance.
• Opportunities for professional development and career advancement.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.