Katalyst CRO ยท 2 months ago
CQV Engineer
Glendale, CA
Contract
Onsite
Mid, Senior Level
2+ years expKatalyst CRO is a large pharmaceutical company seeking a CQV Engineer for a 12-month onsite project in Los Angeles. The role involves managing project lifecycle documentation, conducting risk assessments, and overseeing installation and qualification processes to ensure compliance with quality standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
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
Qualification
Required
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
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
Preferred
Facilities CQV experience including EMPO, Vessel IOV and IOPQ including mixing and temp mapping
Cleanroom qualification experience is a plus
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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