Information Technology, Validation Engineer and Technical Writer

Posting Date 1 month ago(1/15/2018 10:15 AM)
Requisition ID
2018-3721
Job Location(s)
Indianapolis IN United States
Travel
10-20%
Shift Type
First
Position Type
Full Time
Company
Cook Regentec LLC
Category
Information Technology

Overview

The primary function of the Validation Engineer and Technical Writer at Cook Regentec will be maintaining lifecycle management of various commissioning, qualification, and/or validation facets within our client’s Biotechnology, Medical Device, and Pharmaceutical sites.  This will include the need to develop, implement, and execute tests based on standards, user requirements, end user scenarios and design specifications to ensure the highest level of quality possible for a software release.

Responsibilities

• Extensive experience with the Software Development Lifecycle (SDLC) and Computer System Validation (CSV) experience
• Familiarity with FDA CFR Part 11 for Electronic Records and Signatures
• Familiarity with Annex 11, The Rules for Governing Medicinal Products in the European Union
• Familiarity with FDA Guidelines, USP, GAMP 5, ISO, etc.
• Project Validation and/or Master Validation Planning.
• Validate proper design and operation of chosen software
• Design and deliver end user and internal documentation for software products, including User Guides, Installation Guides, Release Notes, Online Help, and other documentation as required
• Develop test plans for small/medium/large size projects including embedded systems and applications
• Design and execute manual and automated test cases based on standards, user requirements, end-user scenarios and design specifications
• Accurately update and complete documentation on test results and analysis

• Ability to proactively identify issues, troubleshoot issues, and escalate concerns as appropriate
• Triage test failures and problems. Provide clear and concise defect reports to the responsible individuals in a timely manner and assist in additional defect characterization as needed to resolve the issues
• Executes and implements appropriate Risk management strategies to prevent unanticipated failure modes and/or quality issues
• Adheres to strict procedural, regulatory, and quality standards including thorough and accurate documentation and testing protocols
• Participate in project planning and design discussions as a member of a cross-functional team
• Work with peers to achieve project, personal and team goals
• Maintain and enhance job-related skills by self-teaching or participating in appropriate training and development programs
• Responsible for audits/inspections of validation exercises
• Support Quality documentation of Validation and IT process in Quality Document Management System
• Manage document libraries, ensuring files are organized, easily accessible, and archived when appropriate

Qualifications

• Bachelor’s Degree in Computer Science, Electrical Engineering, Engineering Technology, or equivalent
• Minimum of two (2) years validation/testing experience
• Familiarity with Quality Systems Regulations (e.g. FDA CFR21 PART 11, ANNEX 11, GAMP 5, ISO 13485, ISO 9001)
• Advanced Knowledge of SDLC and CSV

• Advanced Software Validation
• Advanced Process Validation
• Excellent Documentation Skills
• Advanced Problem and Risk Analysis and Resolution

 

Physical Requirements:

• General office environment
• Must be able to sit for long periods of time
• 10% travel

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