Sr Validation Scientist

We are seeking a highly skilled and independent Validation Engineer to provide technical support for process and equipment upgrades, replacements, and modifications in laboratory, manufacturing, or manufacturing support environments. The ideal candidate will possess advanced validation expertise and demonstrate exceptional problem-solving, leadership, and technical skills. This role involves ensuring the success of complex projects, driving innovative solutions, and serving as a technical expert for validation programs and practices.

Responsibilities

• Troubleshoot systemic validation issues and apply advanced validation engineering principles to complex process or system modifications.
• Develop and implement validation engineering policies and procedures affecting multiple organizational units.
• Employ advanced validation techniques to create innovative solutions to technical problems.
• Assess, organize, analyze, and interpret results for operational issues or validation projects.
• Lead validation responsibilities for engineering projects while managing schedules, budgets, and quality constraints.
• Collaborate with cross-functional teams (manufacturing, utilities, facilities, labs, quality assurance) to establish requirements for system or process modifications.
• Supervise and coordinate the work of engineers and technicians on project or ongoing bases.
• Develop project budgets and monitor expenditures within the scope of the project.
• Represent the organization as the prime technical contact on contracts and validation projects.
• Interact with senior external personnel and regulatory bodies (e.g., FDA) to endorse and advance validation programs.
• Ensure alignment between industry regulatory trends and established corporate directions.
• Provide technical guidance and project leadership to teams, ensuring successful completion of broad programs.
• Delegate tasks effectively, develop schedules, and manage project resources to achieve objectives.
• Foster collaboration among internal and external stakeholders, including contractors and vendors.
• Provide expertise in equipment qualification, cleaning validation, sterilization, and process validation.
• Support validation responsibilities for new product introductions, optimization projects, and commercial manufacturing.
• Apply creative problem-solving skills and scientific principles to address technical challenges.

Key Competencies and Skills

• Advanced knowledge of validation processes and requirements, including equipment qualification and cleaning validation.
• Ability to lead and supervise project teams and manage technical resources effectively.
• Strong problem-solving abilities requiring application of scientific theories and engineering principles.
• Exceptional skills in negotiation, collaboration, project cost development, conflict resolution, leadership, and team building.
• Experience with project management tools and techniques.
• In-depth understanding of financial analysis tools.

Education and Experience

• Doctorate degree OR
• Master’s degree with 3+ years of directly related experience OR
• Bachelor’s degree with 5+ years of directly related experience OR
• Associate’s degree with 10+ years of directly related experience OR
• High school diploma/GED with 12+ years of directly related experience.

Preferred Qualifications

• Strong background in engineering (any field) or scientific disciplines such as Biology, Microbiology, Biotechnology, or Chemistry.
• Experience in regulated environments (Biotechnology, Pharmaceutical, Medical Devices) with emphasis on validation processes (preferably process validation).