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Senior Validation Scientist (Biotechnology) 3277357
ProQualityNetworkJuncos, PR, USHace 23 días
Descripción del trabajoExperience in : Aseptic Process Validation and Techniques. Environmental Monitoring Performance Qualifications. Environmental Characterizations. Airflow Visualization. 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. 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. 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. 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.
Job Description
Job Description
Job Opportunity : Senior Validation Scientist
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 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.
- Masters Degree : 3 years of directly related experience.
- Bachelors Degree : 5 years of directly related experience.
- Associates Degree : 10 years of directly related experience.
- High School Diploma / GED : 12 years of directly related experience.
Preferred Qualifications
Key Responsibilities
Knowledge and Competencies
Impact and Liaison
Competencies and Skills
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!
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Validation Scientist • Juncos, PR, US
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