Sr. Validation Scientist
Job Opportunity: Senior Validation Scientist
Location: Juncos, PR (Open to U.S. Citizens who are locals in Puerto Rico)
Shift: 100% Onsite on Administrative Shift
Duration: Approximately 10 months
Positions Available: 1
Summary
We are seeking a Senior Validation Scientist to 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.
If you are a highly skilled professional ready to take on a challenging and impactful role, we invite you to apply inside the job description with your updated resume. Take the next step in your career and contribute to a dynamic and innovative team!