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.

• 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.

• 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.
• Change Control:
• 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.

• 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.