CQV Engineer

Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. We are currently seeking a Senior Quality Validation Engineer who is passionate about ensuring the highest standards of quality in the pharmaceutical and biotechnology sectors. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!

We are seeking a highly motivated and skilled Life Science Professional with 1-2 years of experience in R&D-based projects and process improvement to join our dynamic team. This role requires someone with hands-on experience in a 5S and lean manufacturing environment and proficiency in GxP documentation. The ideal candidate will have strong problem-solving skills, experience leading projects, and a proven track record of using various risk management tools to drive solutions in a collaborative team environment.

Key Responsibilities:

• Lead R&D-based projects to ensure successful product development and optimization within a regulated environment.
• Work with cross-functional teams to create, revise, and execute GxP documentation (Good Manufacturing Practices, Good Laboratory Practices) for process validation and compliance.
• Utilize Risk Assessment, FMEA (Failure Mode and Effects Analysis), and Process Value Mapping to identify process bottlenecks and drive improvements.
• Implement Six Sigma methodologies (Green Belt level) to enhance process efficiency and quality.
• Perform troubleshooting in manufacturing processes, identifying root causes, and implementing corrective actions.
• Participate in product development processes, using Design of Experiments (DoE) to optimize product designs and outcomes.
• Conduct IQ, OQ, PQ validation activities to ensure equipment and systems comply with regulatory standards and operate as expected.
• Collaborate with teams to ensure smooth execution of projects in accordance with timelines and quality standards.

Core Competencies:

• Six Sigma - Green Belt Certification
• Validation: Experience in IQ, OQ, PQ for equipment and process validation
• Product Development: Proficient in Design of Experiments (DoE)
• Quality Control: Strong foundation in quality assurance practices
• P&ID (Piping & Instrumentation Diagrams) and Electrical Drawing Analysis
• Hands-on experience with Risk Assessment, FMEA, and process optimization techniques.
• Well-versed in Lean Manufacturing principles, including 5S methodology, to ensure continuous improvement in operations.
• Strong teamwork and collaboration skills, ensuring effective communication and shared success across projects.

Requirements

Required Qualifications:

• 3-5 years of hands-on experience in an R&D or manufacturing environment, specifically in the life sciences sector.
• Solid knowledge of 5S, Lean Manufacturing, and continuous improvement techniques.
• Experience in leading and participating in process validation and product development projects.
• Proficient in the use of risk management tools like FMEA and Process Value Mapping.
• Strong communication and interpersonal skills, with the ability to work collaboratively in a team setting.
• A passion for innovation, problem-solving, and contributing to the overall success of the team and projects.

Preferred Qualifications:

• Previous experience in pharmaceuticals, biotech, or related life science sectors.
• Familiarity with regulatory standards, such as FDA, ISO, and other applicable guidelines.
• Familiarity with Automation and Robotics used in life science manufacturing.

Benefits

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.

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)