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Validation Specialist

Irvine, CA 92614

Posted: 04/02/2024 Employment Type: Contract Job Category: Engineering Job Number: 603924 Is job remote?: No Country: United States

Job Description


Target PR Range: 52-62/hr
*Depending on experience

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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Irvine, CA

Take the next step in your career journey in the vibrant city of Irvine, California! Nestled in the heart of Orange County, this thriving community offers unparalleled growth opportunities and an unbeatable quality of life. With its close proximity to stunning beaches, world-class shopping at South Coast Plaza, a bustling culinary scene featuring diverse cuisine options, and cultural attractions like the Irvine Museum and Irvine Barclay Theatre, Irvine has something for everyone. Whether you're into outdoor activities in Irvine Regional Park or catching a game at the Angel Stadium of Anaheim or the Honda Center, this region has it all. Explore our job listings today and discover why Irvine is the perfect place to advance your career!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.