Process Validation Specialist

Mentor Technical Group; Juncos (PR); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading life science engineering firm seeks a Validation Specialist in Juncos, Puerto Rico. The role involves planning, coordinating, and executing validation activities for aseptic manufacturing processes while ensuring compliance with FDA regulations. Candidates must have a Bachelor's degree in Life Sciences or a related field, along with 5-10 years of relevant experience. Strong communication, problem-solving, and analytical skills are essential for success in this position.

Qualifications

• Minimum of 5–10 years’ experience in validation activities in FDA-regulated environments.
• Strong experience in Aseptic Process Validation and related techniques.
• Proficiency in English and strong collaboration skills.

Responsibilities

• Plan, coordinate, and execute validation activities for manufacturing processes.
• Prepare, review, and approve validation protocols and reports.
• Perform Aseptic Process Validation and execute validation activities in clean rooms.

Skills

Aseptic Process Validation

Environmental Monitoring

Performance Qualifications

Environmental Characterizations

Problem-solving skills

Analytical skills

Organizational skills

Communication skills

Education

Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Engineering, or related field

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, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities

• Plan, coordinate, and execute validation activities for parenteral and aseptic manufacturing processes.
• Prepare, review, and approve validation protocols, reports, and related documentation.
• Perform Aseptic Process Validation, including Environmental Monitoring, Performance Qualifications, Environmental Characterizations, and Airflow Visualization (Smoke Tests).
• Execute validation activities inside clean rooms, following GMP, SOPs, and regulatory requirements.
• Collaborate with QA/QC, production, and engineering teams to ensure validation timelines are met and deviations are addressed promptly.
• Monitor progress of validation projects, identify potential delays, and propose corrective actions.
• Maintain accurate records of all validation activities, including schedules, results, and approvals.
• Support continuous improvement initiatives related to validation processes and compliance.

Qualifications / Requirements / Knowledge / Education / Skills

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Engineering, or related field.
• Minimum of 5–10 years’ experience in validation activities in FDA-regulated environments, preferably in parenteral or aseptic manufacturing.
• Strong experience in Aseptic Process Validation, Aseptic Techniques, Environmental Monitoring, Performance Qualifications, Environmental Characterizations, and Airflow Visualization (Smoke Tests).
• Experience writing protocols, validation reports, and executing procedures inside clean rooms.
• Knowledge of GMP, FDA regulations, and quality systems.
• Proficiency in English; additional language skills are a plus.
• Strong analytical, organizational, and problem-solving skills.
• Excellent communication skills and ability to collaborate effectively across multidisciplinary teams.

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.