Process Validation Specialist

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

Job summary

MENTOR Technical Group Corporation in Juncos, Puerto Rico is seeking a skilled Validation Specialist with expertise in aseptic manufacturing processes. Responsibilities include planning and executing validation activities, preparing documentation, and collaborating with teams to ensure compliance with regulatory standards.

The ideal candidate must have a Bachelor’s degree in a related field, and 5-10 years of experience in validation within FDA-regulated environments. Strong analytical and communication skills are essential for this role.

Qualifications

• 5–10 years’ experience in validation activities in FDA-regulated environments.
• Experience writing protocols and validation reports.
• Knowledge of GMP and FDA regulations.

Responsibilities

• Plan, coordinate, and execute validation activities for manufacturing processes.
• Prepare, review, and approve validation protocols and documentation.
• Collaborate with QA/QC, production, and engineering teams.

Skills

Aseptic Process Validation

Environmental Monitoring

Analytical skills

Problem-solving skills

Communication skills

Education

Bachelor’s degree in Life Sciences

Pharmaceutical Sciences

Engineering

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 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.