We are seeking a highly motivated and detail-oriented Engineer I to join our Clinical Biomarker Laboratory team. In this role, you will be responsible for executing commissioning, qualification, and validation (CQV) activities, ensuring that equipment and systems remain in a qualified, compliant state within a GCLP/GLP laboratory environment. You will collaborate closely with Lab Operations, Lab Compliance, and R&D Quality to ensure that qualification activities are completed successfully. This position offers an exciting opportunity to work in a fast-paced, innovative environment. The role reports to the Associate Director of Laboratory Compliance.

What You'll Do:

• Execute commissioning, qualification, and validation activities to ensure compliance with GCLP guidelines and GLP regulations.
• Author and execute documentation for design, commissioning, qualification, and validation, supporting compliance with all applicable specifications and procedures.
• Ensure the timely resolution of compliance documentation and quality system issues.
• Investigate deviations related to qualification and validation activities and drive corrective actions.
• Participate in cross-functional teams to meet project timelines and business objectives, while adhering to regulatory requirements.
• Develop, review, and ensure adherence to Standard Operating Procedures (SOPs).
• Participate in training programs to support CQV requirements.

What You'll Need:

• Bachelor’s degree in Engineering, Science, or a related technical field.
• Must have CQV experience

Preferred Qualifications:

• Understanding of commissioning, qualification, and validation principles.
• Strong technical documentation skills with attention to detail, ensuring compliance with site procedures and regulatory standards.
• Structured problem-solving skills, with the ability to identify root causes and develop corrective and preventative actions.
• Excellent written and verbal communication skills, with the ability to present and influence at all levels.
• Strong collaboration skills and the ability to take ownership of tasks and follow through.
• Proficiency in MS PowerPoint, MS Project, and strong organizational skills.
• A passion for contributing to a high-growth, innovative company environment that values being Bold, Relentless, Curious, and Collaborative.

Why Join Us: We are committed to pushing the boundaries of science to deliver life-changing treatments. If you're looking to make an impact in a rapidly growing company, this role offers an exciting opportunity to contribute to groundbreaking work in the clinical biomarker space.