19 Apr

Senior Quality Validation Engineer Jobs Vacancy in Tellus Solutions South San Francisco

Position
Senior Quality Validation Engineer
Company
Tellus Solutions
Location
South San Francisco CA
Opening
19 Apr, 2018 30+ days ago

Tellus Solutions South San Francisco urgently required following position for Senior Quality Validation Engineer. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Senior Quality Validation Engineer Jobs Vacancy in Tellus Solutions South San Francisco Jobs Details:

General Position Summary/Purpose:
The Senior Quality / Validation Engineer will be responsible for defining Computer System Validation (CSV) methodology, and support IT and Business to validate their business systems using the defined CSV process. The individual will be responsible for leading and performing risk-based validation of GxP systems, develop validation documents, and communicate project progress throughout the system lifecycle. The individual will be involved with Audit Remediation, and SOP Authoring. The individual will provide hands-on end user support and issue resolution for GxP controlled laboratory equipment, servers, desktops, and software packages. The individual will perform testing of Laboratory system upgrades, create system documentation in accordance to computerized system and equipment validation protocols. Deliverables will include System Risk Assessments (SRAs), Requirements Traceability Matrix, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Facilitate verification and validation activities such as User Acceptance Testing (UAT), test execution, documentation review, and approval. The individual must have hands-on experience in a Bio-Tech / Pharmaceutical GxP environment.

Key Accountabilities / Core Job Responsibilities:

  • Responsible and accountable for the development and delivery of a complete package
of validation documents and system-specific SOP, Work Instruction, or FORM: User

Requirement Specification (URS), Validation Project Plan (VPP), Installation Protocol (IP),

Installation Report (IR), Functional Requirement Specification (FRS), Hazard Analysis (HA), User Testing Protocol (UTP), User Test Report (UTR), Traceability Matrix (TM), System Release Report (SRR), Validation Report (VR), System Configurations Specification (SCS), Administration and User SOPs, Work Instruction (WIs), or Forms.

  • Lead and support CSV projects and related activities for IT supported systems. This involves understanding the business, determining business and system requirements, project planning, timeline, and resource allocation, and collaborating with project team members in the development and delivery of validation deliverables including working with business users on developing test cases, performing dry-run, and update test scripts.
  • Oversee and take part in the formal test execution of IP and UTP to ensure the testing was performed appropriately and the test results are compiled in a timely manner.
  • Work collaboratively across functions with Quality, IT, Business, and Vendors to plan, coordinate and execute computer system validation activities, and obtain fully approved documents.
  • Review and/or approve validation documents and related deliverables, such as System Configurations Specification (SCS), executed test scripts, and system-specific Admin and User SOPs.
  • Work closely with IT, QA, or Vendor to create Development, Test, Production environments at the right timing to test and implement a new GxP system into production use that meet the 21 CFR Part 11 requirements. Experienced in linking CSV activities and timeline with the setup and use of various environments appropriately.
  • Drives and coordinates system related Change Requests, Deviations / Non-Conformance, and CAPAs in accordance to governing GMP procedures.
  • Participates in the identification of risks and the development of mitigation strategies
for a GxP system to be validated.

  • Train and serve as coach and mentor for validation staff and business partners.
  • Responsible for ongoing support, maintenance, and management of Enterprise Applications, R&D Lab, GxP and Non-GxP systems.
  • Participate in project planning and project health check reviews.
Qualifications and Requirements:
  • Bachelor's Degree in Computer Science, Information Technology, or related discipline.
  • 10+ years of experience in the Information Technology field.
  • 5+ years of pharmaceutical GxP system validation experience.
  • Excellent communication and technical documentation skills.
  • Strong attention to detail and quality oriented.
  • Strong knowledge of processes and applications related to Clinical Operations, Medical Affairs, Clinical Data Management, Clinical Science, Biostatistics, Lab, Drug Safety & Pharmacovigilance.
  • Strong knowledge of procedures and best practices related to FDA Regulations, EU GMP Annex 11, 21 CFR Part 11, Computer System Validation, GAMP 5, cGxP (cGCP, cGLP, cGMP, cGVP) practices, and other regulations governing drug development and commercialization.
  • System lifecycle (SLC) experience in a regulated environment.
  • Strong experience in managing Change Control for GxP systems, creating Change Control Requests, describe change impact, test plan, perform validation, and write up documentation.
  • Familiar with Operating Systems, Infrastructure, VMWare Virtualization, and cloud-hosted technologies.
  • Experience with SOP authoring relative to Bio Tech processes and applications.
  • Ability to articulate complex technical problems and business value to a wide business audience.
  • Ability to troubleshoot issues and work independently with minimal supervision.


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