Senior Validation Scientist - Onsite Biotech Process & Equipment

ProQuality Network; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

ProQuality Network in Juncos, PR seeks a Senior Validation Scientist to provide independent validation engineering support for process and equipment upgrades, replacements, and modifications in laboratory, manufacturing, or support environments.

Role involves advanced problem-solving, developing innovative solutions, and collaboration across departments to ensure compliance and operational excellence. Onsite, 7-month assignment, with 100% on-site schedule.

Qualifications

• Experience in aseptic validation processes and techniques.
• Environmental Monitoring Qualifications experience preferred.
• Strong regulatory knowledge of FDA or equivalent bodies.
• Ability to lead validation projects across multiple units.

Responsibilities

• Troubleshoot systemic validation issues and implement solutions.
• Apply advanced validation engineering principles to major system or process modifications and capital projects.
• Develop, organize, analyze, and present results for validation projects of significant scope and complexity.
• Create and implement new validation techniques and procedures.
• Develop and oversee validation policies affecting multiple units.
• Supervise and review work of engineers and technicians on projects.
• Collaborate with manufacturing, facilities, labs, QA, and utilities teams.
• Lead validation activities for complex engineering projects within budget, schedule, and quality constraints.
• Develop departmental or project budgets for larger initiatives.

Skills

Equipment qualification

Cleaning validation

Sterilization

Regulatory understanding

Leadership skills

Project management

Problem solving

Education

Doctorate Degree

Master’s Degree

Bachelor’s Degree

Associate’s Degree

High School Diploma/GED

Job description

ProQuality Network in Juncos, PR seeks a Senior Validation Scientist to provide independent validation engineering support for process and equipment upgrades, replacements, and modifications in laboratory, manufacturing, or support environments.

Role involves advanced problem-solving, developing innovative solutions, and collaboration across departments to ensure compliance and operational excellence. Onsite, 7-month assignment, with 100% on-site schedule.