Sr. Validation Scientist 3401728

Job DescriptionJob Description

Sr. Validation Scientist

Location: East of Puerto Rico (Open for Puerto Rico )

Positions: 1

Period: Approximately Three Months

Summary

Our client is seeking a highly skilled Sr. Validation Scientist to provide and/or lead technical validation engineering support for process and equipment upgrades, replacements, and modifications within laboratory, manufacturing, or manufacturing support environments. This role requires independent problem-solving skills, advanced technical expertise, and the ability to guide projects of significant scope and complexity.

Qualifications

• Education in Microbiology, Biology, Chemistry, or Engineering.
• Experience in Aseptic Process Simulation (Media Fills), Airflow Visualization Studies (Smoke Studies), and Environmental Characterization/Qualification.
• Background in Parenteral Manufacturing and experience with isolators.

Key Functions

• Troubleshoot systemic validation issues.
• Apply advanced and diverse validation engineering principles to major system or process modifications and capital projects.
• Develop, organize, analyze, and present results for operational issues or large-scale validation projects.
• Complete complex or novel assignments requiring the creation of new or improved validation techniques and procedures.
• Establish validation engineering policies and procedures impacting multiple organizational units.
• Supervise, coordinate, and review work of engineers and/or technicians.
• Employ advanced validation engineering techniques and modifications within the field of expertise.
• Apply knowledge of validation engineering principles to a broad variety of related fields.
• Develop technical solutions to complex problems using ingenuity and creativity.
• Collaborate with manufacturing, process development, utilities, facilities, laboratories, and quality assurance to develop requirements and recommendations for large-scale or complex system/facility modifications.
• Partner with project managers to complete validation responsibilities within schedule, budget, and quality parameters.
• Develop and manage departmental or project budgets.
• Maintain prompt and regular workplace attendance.
• Perform other duties as assigned.

Knowledge & Expertise

• Advanced validation knowledge, including equipment qualification, cleaning, and sterilization.
• Broad technical expertise with an understanding of related disciplines.
• Familiarity with regulatory trends and requirements; ability to connect regulatory direction with company programs.
• Experience representing organizations in technical validations before regulatory bodies (e.g., FDA or equivalent).

Problem-Solving & Decision-Making

• Provide practical, creative solutions to complex problems.
• Exercise considerable latitude in determining technical objectives and methods.
• Work reviewed from a long-term perspective for overall results.

Impact & Leadership

• Lead major programs and potentially supervise staff or project teams.
• Guide successful completion of significant projects with measurable business impact.
• Serve as a primary technical contact for contracts and projects, interacting with senior external stakeholders.

Education & Experience

• Doctorate degree; OR Masters degree and 3 years of directly related experience; OR Bachelors degree and 5 years of directly related experience; OR Associates degree and 10 years of directly related experience; OR High school diploma/GED and 12 years of directly related experience.

Competencies & Skills

• In-depth knowledge of validation processes and requirements.
• Strong interpersonal skills and ability to adapt to different communication and work styles.
• Capable of managing multiple projects simultaneously.
• Proficiency in schedule development, facilitation, and collaboration.
• Basic project management skills.
• Strong problem-solving abilities applying scientific and engineering theory.
• Working knowledge of financial analysis tools.
• Leadership skills in negotiation, conflict resolution, decision-making, and team building.
• Experience managing contractors and vendors.

If you meet these qualifications and are ready to contribute your expertise to a dynamic and impactful environment, we encourage you to apply by submitting your updated resume through the job description link.