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 munication: 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 standardsDemonstrated 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.

Created: 2025-02-21