CQV Engineer

A large pharmaceutical company in Los Angeles is in immediate need of a CQV Engineer for a 12-month project, this is an onsite position and is 40 hours/week. This project will start in March 2025.

The client needs someone with Facilities CQV experience including EMPO, Vessel IOV and IOPQ including mixing and temp mapping. They have personnel assigned to Utilities (WFI, Alcohol, N2, Compressed Air, etc.), CIP, Filter Press, Centrifuge, CIP skids and Cleaning Validation; this experience is preferred in case they need additional support. The project also requires daily job walks of the construction site daily in full PPE.

Top Requirements:

• BS degree minimum
• 1-4 years of Validation Engineering experience in pharmaceutical industry
• Strong skill set in installation and IQOQ of equipment like centrifuges, filter presses, and processing tanks
• Very strong technical writing/documentation skills
• Very strong communication skills and ability to coordinate with cross-functional teams
• Experience doing job walks with engineers for capital projects
• Must have a positive attitude and ability to multi-task

Full Scope of Project:

Generation and Modification of project lifecycle documentation for LA Plant Site.

• User Requirement Specifications
• Functional Specifications
• Design Specifications
• SOPs
• Management of Change (MOC)
• FMEA
• HAZOPs
• Risk Assessments
• Gap Assessments
• Project Closeout Documentation
• Turnover Package Generation
• Project Change Requests

Construction Activities

• Generate and Manage Safety Management Plans and Documentation
• Disruptive Construction Activity Requests
• Job Hazard Analysis
• Lockout Tag Out Plan
• Hot Work Permitting
• Permit to Work
• Detour Plans
• Construction Signage
• Plant-wide Communications.
• Generate and Manage Quality Management Plans and Documentation
• Construction Control Plan
• Assist in site supervision of construction personnel.

Manage Installation and Operational Commissioning

• Author and Approve
• Execution
• Function Testing
• BOM Updates
• PM Generation
• Asset Lifecycle
• Drawing Updates
• Support site acceptance testing to review system documents and functions during SAT.
• Summary Report

Manage Installation, Operational, and Performance Qualification

• Author and approve.
• Develop and execute qualification protocols.
• Assist with any deviation resolution and handling execution.

Summary Report Training and Documentation

• Train personnel on the operation of the Fractionation process, and related procedures
• Create comprehensive documentation of all validation activities.

Risk Assessment and Mitigation

• Identify and assess potential risks to product quality and patient safety.
• Develop mitigation strategies and contingency plans.

Change Control

• Manage change control for any modifications or updates to the equipment or processes.

Quality Audits

• Conduct internal and external audits to ensure compliance with quality standards and regulations.

Start up support.

• Start up support for process equipment and facility as required.

Installation Qualification

• Equipment installation verification and confirmation that equipment is installed in

Accordance with manufacturer's specifications.

• Document equipment installation and location.

Operational Qualification

• Equipment functional verifications under operational conditions.
• Conduct testing of equipment functionality and performance.
• Documenting of all test results and deviations

Performance Qualification

• Confirmation of the fractionation performance
• Validate the manufacturing process and critical process parameters.
• Generate and review batch records and documentation.

Process Validation

• Conduct process validation studies to ensure consistent product quality.
• Perform risk assessments and implement process controls.
• Develop and validate analytical methods for product testing.

Cleaning Validation

• Validate the cleaning procedures for the equipment to prevent cross contamination.
• Document cleaning validation protocols and results.

Facility Qualification

• Conduct validation of critical facility systems

Software Validation

• Validate any software system used in the fractionation process, including data management and process control systems.

Validation Reports

• Compile validation reports summarizing all activities, results, and conclusions.
• Include recommendations for ongoing monitoring and maintenance.