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.

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.

• 3-10 years of Validation Engineering experience in pharmaceutical industry
• Strong skill set in installation and IQOQ of equipment like centrifuges, filter presses, and processing tanks
• Cleanroom qualification experience is a plus
• 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
• Must be committed to supporting a long-term project that could go for 2 years
• Must be available to support other shifts as requested by the client, this could happen on short notice.

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
• Gap Assessments
• Project Closeout Documentation
• Turnover Package Generation
• Project Change Requests

• Generate and Manage Safety Management Plans and Documentation
• Disruptive Construction Activity Requests
• Permit to Work
• Detour Plans
• Construction Signage
• Generate and Manage Quality Management Plans and Documentation
• Construction Control Plan
• Assist in site supervision of construction personnel.

• 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

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

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

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

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

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

• Start up support for process equipment and facility as required.
• Equipment installation verification and confirmation that equipment is installed in accordance with manufacturer s specifications.
• Document equipment installation and location.

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

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

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

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

• Conduct validation of critical facility systems

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

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