Title :- CQV Lead Engineer openings - AbbVie

Abbvie- Cinncianatti,OH (Onsite)

3/1/25-7/31/26

The Cincinnati AbbVie site is currently engaged in a major capital project. Scope includes construction of a new QC Laboratory, relocating existing lab equipment, construction of a new packaging line suite, and installation of a new packaging line.

Description:

Review all validation documents to meet Pharma & Abbvie standards. Examples are typically available.

Documents may include:

• User Requirement Specifications
• Commissioning
• IQ, OQ, PQ
• Calibration
• Standard Operating Procedures
• Preventative Maintenance Plans
• Equipment will include laboratory equipment relocation, facility and utility equipment, and oral solid dose packaging line equipment.
• Communicate with staff & project manager.
• Monitor the progress of the documents to keep it on schedule and adjust workload to adhere to the deadline.
• Serve as a point contact for the validation documents to ensure team actions remain in constructive collaboration.
• Perform quality control on the Project throughout development to maintain the standards expected.
• Develop and maintain weekly the project master validation tracker
• Set direction for the team priorities looking ahead to maintain schedule.
• Provide updates for 3rd level schedule.
• Attend project meetings, & document all issues.
• Have weekly one on one sessions with the project manager regarding progress.
• Input to additional staffing needs.
• Define all of the required documents.
• Lead all validation activity on site for the project from beginning to end.
• Input to project timetables.
• Set weekly direction for the team priorities by looking ahead to maintain schedule. Communicate concerns with project team.
• Implement conflict management when necessary.
• Perform quality checks of each team member's work output.
• Ensure that all product sample requirements are met in a timely fashion for all testing & validation.
• Author and execute own documents as workload allows.