Aseptic Process Validation Lead

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 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.