Job Description

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values.

Position Overview: We are seeking an experienced Senior Engineer specializing in validation and Corrective and Preventive Actions (CAPA). The ideal candidate will have extensive expertise in validation processes and a proven track record in leading investigations to ensure compliance and continuous improvement.

Key Responsibilities:

• Develop and present comprehensive Investigation Plans to management and CAPA review boards.
• Define, measure, and analyze key elements of investigations.
• Determine the scope of investigations, assuming ownership and leading the Investigation phase of CAPA processes.
• Identify and assemble a cross-functional Investigation Team.
• Confirm corrections and containment strategies based on investigation findings.
• Utilize appropriate investigation tools to assess data and processes.
• Identify necessary data sources and gather relevant data for analysis.
• Investigate root causes and document results comprehensively.
• Communicate investigation results effectively to impacted departments.
• Ensure all investigations adhere to CAPA procedures, including data entry requirements.
• Maintain accurate and current investigation records throughout their lifecycle.
• Collaborate with Action Owners and CAPA Owners to develop Action and Effectiveness Plans.
• Document Action Plans, including acceptance criteria, timelines, and opportunities for improvement.

Requirements

Requirements:

• Bachelor’s degree in Engineering, Science, or related field; advanced degree preferred.
• Extensive experience in validation processes and CAPA systems.
• Strong analytical skills and familiarity with investigation tools and methodologies.
• Experience working cross-functionally in a regulated environment.

Skills:

• Proficient in data analysis and documentation.
• Strong problem-solving skills with a focus on root cause analysis.
• Knowledge of industry regulations and standards related to validation and CAPA.

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

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