Computer Validation Specialist III

Location
San Francisco, CA, United States
Posted
Jan 13, 2021
Ref
5262-850-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Computer Validation Specialist III.

Supports IT and various Business groups to validate their business systems using the defined CSV process and help IT Management ensure the activities of the IT group are in compliance with SOX and cGxP control requirements. The four primary responsibilities are Validation, SOX Administration, Documentation, and Training. As a member of the IT team, takes a proactive posture to evolve procedures and practices to support new technology and changes in business requirements. 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.

Essential Duties and Responsibilities

Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Validation:

Responsible and accountable for the development and delivery of a complete validation package. 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.

Works collaboratively across functions with Quality, IT, Business, and Vendors to plan. Coordinates and executes computer system validation activities, and obtains fully approved documents.

Reviews and/or approves validation documents and related deliverables, including system-specific Admin and User SOPs.

Documentation:

Maintains multiple record types (log books, Excel spreadsheets, physical documents, etc.) of all Change Requests (CRs), issuing new change request numbers to IT staff as requested.

Reviews all CRs for compliance with applicable SOX, cGxP and IT quality requirements, routing only those CRs that meet those requirements. Ensures the Change Review Board (CRB) meets as required and all identified issues from the CRB are followed up on.

Provides updates on the status of Open Change Requests to IT Management on a periodic basis. Supports and performs IT Quality document control activities in order to ensure compliance within the controlled document management system both electronically and manually.

Maintains multiple record types (Excel spreadsheets, document lifecycle versions, as well as physical and electronic copies, etc.) of all IT Quality Documents (ITQDs) including, but not limited to i) IT quality system level documents, ii) IT arrangements, iii) access forms, and iv) IT system level passwords. Reviews all ITQDs for compliance with applicable SOX, cGxP and IT quality requirements, routing only those ITQDs that meet the requirements.

Assists in gathering and generating the system access review and document access review reports/memos on a periodic basis.

Provides guidance and assists IT staff to meet applicable ITQD requirements as time permits. Reviews and suggest revisions to ITQDs to help streamline IT operational efficiency.

Performs periodic review of SOPs and updates and routes SOPs, if needed.

SOX Administration:

Maintains, revises and issues the IT General Computer Controls (IT GCC) and associated tests for these IT GCC's on an annual basis based on input from annual SOX Testing, IT Management and external audit results.

Ensures the IT GCC's are performed throughout the year escalating to IT management as needed.

Maintains and organized the results of all IT GCCs to ensure accessibility is readily available to IT management at all times and as needed.

Assists in the preparation of IT GCCs. Performs extensive annual IT GCC testing and reviews results with Nektar internal audit, preparing follow-up procedures on internal audit recommendations.

Training:

Generates monthly/quarterly training reports and follows up with the defaulters. Assigns training to new employees and vendors and ensures completion. May provide training to new employees and helps maintain the training program by updating training curriculums.

Other duties as assigned.

Minimum Qualification Requirements

Bachelor's Degree in Computer Science, Information Technology, or related discipline. 5+ years of relevant and related 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.