Shoolin Inc ยท 1 day ago
Validation Engineer
California, United States
Contract
Onsite
Entry, Mid Level
1+ years expShoolin Inc is a large pharmaceutical company seeking a Validation Engineer for a 12-month onsite project in Los Angeles. The role involves managing validation activities, generating project lifecycle documentation, and ensuring compliance with quality standards in the pharmaceutical industry.
Artificial Intelligence (AI)Big DataCloud ComputingInformation TechnologyInternet of ThingsSoftware
Hiring Manager
D Sai Nagesh
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
Start up support
Start up support for process equipment and facility as required
Installation Qualification
Equipment installation verification and confirmation that equipment is installed in Accordance with manufacturer's specifications
Document equipment installation and location
Operational Qualification
Equipment functional verifications under operational conditions
Conduct testing of equipment functionality and performance
Documenting of all test results and deviations
Performance Qualification
Confirmation of the fractionation performance
Validate the manufacturing process and critical process parameters
Generate and review batch records and documentation
Process Validation
Conduct process validation studies to ensure consistent product quality
Perform risk assessments and implement process controls
Develop and validate analytical methods for product testing
Cleaning Validation
Validate the cleaning procedures for the equipment to prevent cross contamination
Document cleaning validation protocols and results
Facility Qualification
Conduct validation of critical facility systems
Software Validation
Validate any software system used in the fractionation process, including data management and process control systems
Validation Reports
Compile validation reports summarizing all activities, results, and conclusions
Include recommendations for ongoing monitoring and maintenance
Qualification
Required
BS degree minimum
1-4 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
Preferred
Facilities CQV experience including EMPO, Vessel IOV and IOPQ including mixing and temp mapping
Experience with Utilities (WFI, Alcohol, N2, Compressed Air, etc.), CIP, Filter Press, Centrifuge, CIP skids and Cleaning Validation
Company
Shoolin Inc
Shoolin-Inc staffing, specializes in providing world class recruiting services to companies in the Healthcare, IT, and Engineering sectors.
51-200 employees
H1B Sponsorship
Shoolin Inc 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 (81)
2024 (45)
2023 (48)
2022 (36)
2021 (29)
2020 (18)
Funding
Current Stage
Growth StageCompany data provided by crunchbase