Sr. Computer Validation Specialist

San Francisco, CA, United States
Apr 05, 2019
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Supports the IT and various Business groups to validate their business systems using the defined CSV process.

Leads and performs risk-based validation of GxP systems, develops validation documents, and communicates project progress throughout the system lifecycle. Validates system implementations, system upgrades and creates system documentation in accordance with computerized system validation plan and protocols. Deliverables will include Validation Plan, User and Functional Requirements, Requirements Traceability Matrix (RTM), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Validation Summary report. Facilitates verification and validation activities such as User Acceptance Testing (UAT), test execution, documentation review, and approval. Participates in Audit and Inspection support and remediation, and SOP authoring and revision. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables. Acts independently to determine methods and procedures on new assignments. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Uses professional concepts to achieve objectives in creative and effective ways. Responsible and accountable for the development and delivery of a complete validation package Requirement Specification (URS), Validation Project Plan (VPP), Installation Protocol (IP), Functional Requirement Specification (FRS), Operation Qualification(OQ), Performance Qualification (PQ), Traceability Matrix (TM), Validation Report (VR), System Configurations Specification (SCS), Administration and User SOPs, Work Instruction (WIs), or Forms. Leads and supports CSV projects and related activities for IT supported systems. This involves understanding the business, determining business and system requirements, project planning, timeline, 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 updating test scripts. Oversee and take part in the formal test execution of IQ, OQ and/or PQ 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 Configurations Specification (CS), 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. Drives and coordinates system related Change Requests and Deviations / Non-Conformance, in accordance to governing GxP procedures. Other duties as assigned.

Bachelor's Degree in Computer Science, Information Technology, or related discipline. 8+ 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) 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 Pharma/BioTech processes and applications. Ability to articulate technical problems and business value to a wide business audience. Ability to troubleshoot issues and work independently with minimal supervision.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.