CQV Engineer

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.