Redbock - an NES Fircroft company · 1 day ago
CQV Engineer
LA Metro Area
Contract
Onsite
Mid, Senior Level
3+ years expRedbock, an NES Fircroft company, is seeking a CQV Engineer for a 12-month project with a large pharmaceutical company in Los Angeles. The role involves managing validation activities, conducting risk assessments, and ensuring compliance with quality standards in a construction environment.
BiotechnologyConsultingMedical DevicePharmaceutical
No H1B
Responsibilities
Generate 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
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
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
Qualification
Required
BS degree minimum
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
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
Redbock - an NES Fircroft company
Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2018-06-20Acquired
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