-
Engr II, Applications
2 weeks ago
Trinus Corporation Irvine, United StatesSummary: · The Validation Specialist will be responsible for ensuring that system, processes, equipment, and products meet quality and regulatory standards. This role involves testing, verifying and validating various aspects of a product or system to ensure that it perform as in ...
-
Engr II, Applications
1 week ago
Trinus Corporation Irvine, United StatesSummary: · The Validation Specialist will be responsible for ensuring that system, processes, equipment, and products meet quality and regulatory standards. This role involves testing, verifying and validating various aspects of a product or system to ensure that it perform as i ...
-
complaint investgation
3 weeks ago
Intellectt Inc Irvine, United StatesRole: Engr I · Location: Irvine, CA · Duration: 06 Months on W2 · Job Description: · Perform customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective and preventive ...
-
Intellectt Inc Irvine, United StatesRole: Sr Engr · Location: Irvine, CA · Duration: 9 Months · Key Responsibilities: · Lead identification, development, and optimization of complex Manufacturing processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for design for manufacturing and co ...
-
Engineer II-Network Operations
3 weeks ago
TEKsystems Irvine, United StatesJob Description · Job DescriptionOne of our top communications company looking for a Engineer II-Network Operation · Onsite: Irvine, CA · Job Description: · JOB TITLE: Engr II-Ntwk Operations MUST HAVE SKILLS (Most Important): · Associate's degree or two or more years of work ...
-
Director of Undergraduate Student Affairs
3 weeks ago
University Of California Irvine Irvine, United States· Job Opening ID: 67799 Reports To: Professor Working Title: Director of Undergraduate Student Affairs Department: Engr DO Student Affairs Bargaining Unit: 99 FLSA: Exempt Payroll Job Code: Job Location: UCI Campus- Irvine Percent of Time: 100% Work Schedule: 8-5 Employee Class: ...
-
Director of Undergraduate Student Affairs
3 weeks ago
University Of California Irvine Irvine, United States· Job Opening ID: 67799 Reports To: Professor Working Title: Director of Undergraduate Student Affairs Department: Engr DO Student Affairs Bargaining Unit: 99 FLSA: Exempt Payroll Job Code: Job Location: UCI Campus- Irvine Percent of Time: 100% Work Schedule: 8-5 Employee Class: ...
-
R&D Mechanical Engineer(junior)
1 week ago
INTELLECTT INC Santa Ana, United StatesRole: · Engr I · Location: · Santa Ana, CA · Duration: · 12 Months · Job Description · Test, and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop repor ...
-
R&D Engineer
2 weeks ago
INTELLECTT INC Santa Ana, United StatesRole: Engr II, R&D · Location: Santa Ana, CA · Duration: 12 Months · Job Description · Applies knowledge of technical principles and systems/procedures to maintain and optimize CC legacy products. · Essential Job Functions · Test, and/or improve products by developing moder ...
-
Director & Instructor, Construction Management
3 weeks ago
Oregon Institute of Technology Long Beach, United States Full timePosting Details · Position Details Position Type Non Tenure College/Division College of Engr, Tech & Mgmt (ETM) Department Management Hiring Unit Appointment FTE (%) 1.0 Position Terms/Mo 10 Position Summary Department Summary Oregon Tech's Management Department is committed to ...
-
Senior Power System Protection Engineer
4 weeks ago
Black & Veatch Willowbrook, United States**Senior Power System Protection Engineer - US Hybrid** · Date: Apr 16, 2024 · Location: · US · Company: Black & Veatch Family of Companies · We believe real value is powered by the unique skills and experiences of our professionals. The interchange of ideas from a diverse group ...
-
assistant director
1 week ago
City of Long Beach, CA Long Beach, United StatesSalary : $190, $235,000.00 Annually · Location : City of Long Beach, CA · Job Type: Classified - Full-Time, Permanent · Job Number: HDE24-022 · Department: Harbor - (UC) · Division: HARBOR-ENGR-SURVEY · Opening Date: 05/08/2024 · Closing Date: 5/29/2024 4:30 PM Pacific · ...
-
assistant director
6 days ago
City of Long Beach, CA Long Beach, United StatesSalary : · $190, $235,000.00 Annually · Location : · City of Long Beach, CA · Job Type: · Classified - Full-Time, Permanent · Job Number: · HDE24-022 · Department: · Harbor - (UC) · Division: · HARBOR-ENGR-SURVEY · Opening Date: · 05/08/2024 · Closing Date: · 5/29/ ...
-
assistant director
1 week ago
City of Long Beach Long Beach, United StatesASSISTANT DIRECTOR - SURVEY · Print ) · Apply · ? · ASSISTANT DIRECTOR - SURVEY · Salary · $190, $235,000.00 Annually · Location · City of Long Beach, CA · Job Type · Classified - Full-Time, Permanent · Job Number · HDE24-022 · Department · Harbor - (UC) · Division ...
Engr II, Applications - Irvine, United States - Trinus Corporation
Description
Summary:
The Validation Specialist will be responsible for ensuring that system, processes, equipment, and products meet quality and regulatory standards. This role involves testing, verifying and validating various aspects of a product or system to ensure that it perform as intended and comply with industry standard and regulation.
Job Responsibilities:
Responsible for performing and overseeing the validation of processes, facility, equipment, system, and data cleaning processes.
Develop and coordinate execution of protocols for equipment and process validations, prepare final reports following the execution.
Assist in the implementation and maintenance of the Validation Master Plan.
Configures and tests systems to execute features, integration, and reporting.
Design and develop test strategy and methodology for the validation of the products, processes, and equipment
Initiates investigations of problems and deficiencies to ensure an important level of product quality
Establish the metrics and monitor the performance of processes, equipment, and tools to verify their efficiency, initiate re-validations and process improvement as needed
Qualifications:
Bachelor's degree in a technical field such as computer science, computer engineering or related field required
2-4 years experience required
Strong ability to manage and deal with different cultures and nationalities
Substantial understanding and knowledge of enterprise information systems such as ERP, PLM, CRM, QMS, etc (such as JDE, SAP, Pilgrim) preferred
Experience with FDA guidelines for Software Quality and Systems Validation is a plus
Knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).Experience in authoring/reviewing/approving validation documentation
Implement and maintain software development lifecycle (SDLC) processes.
3+ years of SQL experience, should be able to write complex queries including, stored procedure, creating indexes, CTEs, Functions, and query optimization.
2+ years of Power BI experience using and exporting the data.
Highly Proficient with Microsoft Excel
Proven expertise in usage of MS Office Suite
2+ years of experience with python good to have. (not required)
Ability to adapt to rapidly changing environment
Ability to map, troubleshoot, and optimize interfaces with multiple systems
Experience working in complex, matrixed and global business environment
Ability to develop and maintain business and technical documentation
Develop and execute software test plans, test scenarios, and test cases.
Monitor quality assurance standards and ensure that products meet customer and industry requirements.
Identify, analyze, and document software defects.
Work closely with other engineers and stakeholders to identify areas for improvement.
Develop and utilize test automation tools and techniques.