What are the responsibilities and job description for the Lead CQV Engineer position at EPM Scientific?
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 :
