CQV Engineer

A large pharmaceutical company in Los Angeles is in immediate need of a CQV Engineer for a 12-month onsite project, 40 hours per week. Responsibilities 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.

Requirements BS degree minimum. 2-10 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. #J-18808-Ljbffr