Lead CQV Engineer

Lead CQV Engineer Responsibilities:

• Project Leadership: Guide the team to complete projects on time.
• Document Review: Ensure validation documents meet standards (e.g., User Requirements, IQ, OQ, PQ, Calibration).
• Equipment: Handle validation for lab equipment, facility, utility equipment, and packaging line equipment.
• Communication: Coordinate with team and project manager.
• Progress Monitoring: Track and adjust workloads to stay on schedule.
• Main Contact: Be the go-to person for validation documents.
• Quality Control: Maintain quality standards throughout the project.
• Tracking: Update the project validation tracker weekly.
• Team Direction: Set and communicate team priorities.
• Updates: Provide schedule updates.
• Meetings: Attend and document project meetings.
• Weekly Check-ins: Hold weekly progress meetings with the project manager.
• Staffing: Recommend additional staffing if needed.
• Document Definition: Define all required documents.
• Site Validation Leadership: Lead on-site validation activities from start to finish.
• Timetables: Contribute to project timelines.
• Conflict Management: Handle conflicts if they arise.
• Quality Checks: Review team members' work.
• Sample Requirements: Ensure timely product sample testing.
• Document Authoring: Write and execute documents as needed.
• Recommendations: Suggest design or process changes based on tests.
• Capital Equipment: Understand equipment and process implementation.
• Collaboration: Work with engineering and project teams.
• Regulatory Compliance: Ensure documents meet regulatory standards (FDA, cGMP).
• Master Planning: Plan validation activities.
• Risk Assessment: Identify and mitigate compliance risks.
• Cross-Functional Support: Assist with other CQV activities as needed.

Qualifications:

• Bachelor's degree in a pertinent field (e.g., Engineering, Computer Science, Life Sciences).
• At least 8 years of experience in CQV within a GMP-regulated environment, preferably in pharmaceuticals or biotechnology.
• Extensive knowledge of regulatory compliance requirements (e.g., FDA regulations, cGMP standards, Good Documentation Practice).
• Superior organizational, communication, and documentation skills.
• Strong understanding of validation processes and regulatory requirements specific to automated fill lines, process equipment, and utilities, including GMP, FDA, EMA, and other applicable standards.
• Demonstrated experience leading C&Q efforts on multiple large-scale projects, with references provided to validate successful outcomes.
• Extensive knowledge of industry best practices for commissioning and qualification, with a focus on regulatory compliance.