Lead Aseptic 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

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.