POSITION SUMMARY

The CQV Engineer is responsible for qualifying new, existing, and upgraded systems, equipment, and facilities in a GMP-regulated environment.producing biological vaccines. This hybrid role involves leading validation and qualification efforts while also serving as a hands-on resource for executing qualification activities. The incumbent will participate, lead, and collaborate with various committees, including biosafety, site validation, site quality council, and EHS.

VALIDATION AND QUALIFICATION LEADERSHIP (40%)

• Lead validation and qualification efforts for new, existing, and upgraded systems, equipment, and facilities.
• Develop and implement validation master plans, protocols, and reports in compliance with GMP standards.
• Coordinate and oversee validation activities, ensuring timely completion and adherence to regulatory requirements.
• Participate on capital project teams to provide commissioning, qualification and validation expertise through all project phases.

HANDS-ON EXECUTION OF QUALIFICATION ACTIVITIES (30%)

• Execute qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Execute revalidation activities for existing equipment.
• Support third party contractor executing qualification and revalidation activities.
• Perform risk assessments and develop mitigation strategies for validation projects.
• Conduct testing and data analysis to ensure systems and equipment meet predefined acceptance criteria.

EDUCATION AND EXPERIENCE

• Minimum education of a bachelor’s degree in engineering, life sciences, or a related field.
• 5-7 years of relevant experience in validation and qualification within a GMP-regulated environment.
• Experience with biological vaccine production and aseptic/sterile manufacturing processes is highly desirable.

TECHNICAL SKILLS REQUIREMENTS

• Proficiency in validation and qualification methodologies, including IQ, OQ, and PQ.
• Strong understanding of GMP standards and regulatory requirements for pharmaceutical manufacturing.
• Excellent problem-solving and troubleshooting skills.
• Strong communication and documentation skills.
• Ability to work effectively in a team-oriented environment.
• Effective leadership skills and experience working in cross-functional teams.
• Strong commitment to service and quality.
• Ability to navigate & operate virtual meetings in various platforms.
• Financial & budgeting skills.
• Proficient in English, both oral and written, with sound technical writing skills.