Senior Validation Scientist (Biotechnology) 3277357

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

Senior Validation Scientist (Biotechnology) 3277357

Location: Juncos, PR (Open to U.S. Citizens that resides in Puerto Rico)

Shift: 100% Onsite on Administrative Shift

Duration: Approximately 7 months

Positions Available: 1

Summary

We are seeking aSenior Validation Scientistto provide independent technical validation engineering support for process and/or equipment upgrades, replacements, and modifications in laboratory, manufacturing, or manufacturing support environments. The role involves advanced problem-solving, the development of innovative solutions, and collaboration across various departments to ensure compliance and operational excellence.

Educational and Experience Requirements

• Doctorate Degree: No experience required.
• Master’s Degree: 3 years of directly related experience.
• Bachelor’s Degree: 5 years of directly related experience.
• Associate’s Degree: 10 years of directly related experience.
• High School Diploma/GED: 12 years of directly related experience.

Preferred Qualifications

• Experience in:
• Aseptic Process Validation and Techniques.
• Environmental Monitoring Performance Qualifications.
• Environmental Characterizations.
• Airflow Visualization.

Key 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 engineering projects of significant scope and complexity.
• Create and implement new validation engineering techniques and procedures.
• Develop and oversee validation engineering policies and procedures affecting multiple organizational units.
• Supervise, coordinate, and review the work of engineers and/or technicians on a project or ongoing basis.
• Work collaboratively with manufacturing, process development, utilities, facilities, labs, and quality assurance teams.
• Lead validation activities for complex engineering projects within budget, schedule, and quality constraints.
• Develop departmental or project budgets for larger-scale initiatives.

Knowledge and Competencies

• Technical Expertise: Advanced knowledge in equipment qualification, cleaning validation, and sterilization.
• Problem Solving: Ability to provide innovative and practical solutions to complex problems.
• Regulatory Understanding: Familiarity with regulatory trends and FDA or equivalent regulatory bodies.
• Leadership Skills:
• Lead efforts of peers and supervise staff or project resources.
• Represent the organization as a technical expert and ensure validation program compliance.
• Project Management Skills:
• Develop schedules, facilitate collaboration, and resolve conflicts effectively.
• Manage contractors and vendors, ensuring project completion within constraints.
• Use financial analysis tools and delegate tasks efficiently.

Impact and Liaison

• Play a critical role in the completion of broad programs and projects.
• Decisions and recommendations significantly influence program schedules and resource allocation.
• Represent the organization as the prime technical contact on contracts and projects.
• Interact with senior external personnel on technical matters requiring organizational coordination.

Competencies and Skills

• Ability to handle multiple projects simultaneously.
• Strong problem-solving skills requiring application of scientific and engineering theory.
• Effective negotiation, persuasion, and decision-making abilities.
• Expertise in conflict resolution, leadership, and team building.
• Proficiency in schedule development and project cost estimation.