Senior Validation Specialist - Irvine Site

Are you a seasoned professional with a passion for innovation and a knack for meticulous execution? This Senior Validation Specialist role at our Irvine site presents an exceptional opportunity to contribute to groundbreaking work in Healthcare, Life Science, and Electronics. If you're driven by curiosity and a desire to "work your magic" with science and technology, this position is designed for you.

Key Advantages for Potential Candidates:

• Impactful Work: You'll be at the forefront of validating critical systems that directly contribute to solutions enriching people's lives. Your role is integral to ensuring the quality and reliability of products that serve healthcare, life sciences, and electronics sectors.
• Growth and Development: The company fosters a culture of continuous learning and development. You'll have access to opportunities to hone your skills, expand your expertise, and potentially take on leadership responsibilities. The mention of delivering GMP training programs also signifies a commitment to knowledge sharing and skill enhancement.
• Collaborative Environment: This role emphasizes teamwork. You'll have the chance to lead small multi-disciplinary teams and collaborate with diverse colleagues from various backgrounds, fostering an environment of shared learning and innovation.
• Global Exposure: The willingness to travel occasionally for global assignments offers a unique opportunity to gain international experience and broaden your understanding of validation practices across different regions.
• Subject Matter Expertise: As a Senior Validation Specialist, you will be a key resource, serving as a Subject Matter Expert during internal, customer, and regulatory audits. This positions you as a valuable and recognized contributor.
• Continuous Improvement Focus: The role actively encourages driving continuous improvement initiatives for product quality and regulatory compliance. This means you'll be empowered to identify and implement enhancements, making a tangible difference in processes and outcomes.

Key Considerations for Your Career Path:

• Required Experience: A degree combined with a minimum of 5 years of validation experience in equipment and systems is essential. Prior GMP experience is highly advantageous, suggesting a strong preference for candidates with a solid understanding of regulatory compliance in a pharmaceutical or related environment.
• Validation Lifecycle Management: The responsibilities cover the entire validation lifecycle, from protocol generation and execution to data collation, reporting, and risk assessment. A thorough understanding and proven ability in these areas are critical.
• Quality and Risk Management: Strong skills in generating and approving Quality Risk Assessments, investigating deviations, and implementing CAPAs are paramount. You'll be a guardian of quality and compliance.
• Project Management Acumen: While not explicitly mandatory, project management experience is ideal. This suggests that the ability to plan, organize, and execute validation activities efficiently, often within project timelines, will be a significant asset.
• Communication and Interpersonal Skills: Interacting with customers to understand and meet validation requirements, as well as presenting progress updates, requires excellent communication and interpersonal skills. The ability to effectively convey technical information to various stakeholders is key.
• Safety and Environmental Commitment: Engagement in EHS activities and promoting safety and environmental awareness are integral to the role. Candidates should possess a genuine commitment to these principles.

This Senior Validation Specialist position is more than just a job; it's an invitation to be part of a company that dreams big and is dedicated to sparking discovery and elevating humanity. If you are ready to apply your expertise and drive innovation, we encourage you to explore this exciting opportunity further.