Summary: We are seeking an experienced Validation Engineer to provide technical expertise in process and equipment validation within a laboratory, manufacturing, or manufacturing support environment.
This role involves directing and troubleshooting validation projects, applying advanced engineering principles, and developing innovative solutions to complex validation challenges.
Responsibilities: Troubleshoot systemic validation issues and implement solutions.
Design and execute major system or process modifications and capital projects.
Develop, analyze, and present results for operational or validation engineering projects of significant scope and complexity.
Create and refine validation engineering policies and procedures affecting multiple organizational units.
Supervise and coordinate work of engineers and/or technicians.
Employ advanced validation engineering techniques and adapt approaches for related assignments.
Collaborate with manufacturing, process development, utilities, facilities, labs, and quality assurance to define requirements and recommend solutions for complex projects.
Work with project managers to meet validation responsibilities within schedule, budget, and quality constraints.
Prepare and manage budgets for validation projects or departmental operations.
Knowledge & Skills: Validation Expertise: Proficient in equipment qualification, cleaning validation, and sterilization processes.
Regulatory Knowledge: Understanding of regulatory trends, FDA requirements, and ability to represent the organization as a technical expert.
Problem-Solving: Develop innovative and practical solutions to complex technical problems.
Leadership: Lead project teams, supervise staff, and guide successful completion of major programs.
Collaboration: Effectively interact with internal teams and external stakeholders, representing the organization on technical matters.
Technical Skills: Advanced knowledge of validation engineering principles, project management, and financial analysis tools.
Competencies: In-depth understanding of validation processes and regulatory requirements.
Effective communication and collaboration with diverse teams.
Strong problem-solving and analytical skills.
Proven ability to manage resources, schedules, and budgets efficiently.
Requirements Educational Requirements: Doctorate or Master's degree with 3+ years of related experience, OR Bachelor's degree with 5+ years of related experience, OR Associate's degree with 10+ years of related experience, OR High School Diploma/GED with 12+ years of related experience.
Preferred Qualifications: Hands-on experience with analytical instruments.
Proven ability to manage multiple projects simultaneously.
Strong skills in negotiation, decision-making, conflict resolution, and leadership.
Expertise in vendor and contractor management.
Shift: Administrative Shift