Position:Senior Technical Writer/ Validation Analyst
Location:Cambridge, MA
Duration:6+ Months
F2F required.need candidate with Pharma experience
Senior Technical Writer/ Validation Analyst
This is a senior position reporting to the Project Manager of a large, validated computer system implementation project. This person will act as a subject matter expert in developing an overall testing strategy and will be responsible for creating and maintaining validation documents ensuring compliance with regulatory requirements.
All candidates must have prior experience developing test strategies, writing validation documentation, and supporting computer system validation projects subject to 21CFR11 guidance. Writing samples of validation documentation and non-validation documentation will be requested in addition to references.
The primary functions of this role are as follows:
• contribute directly to the completion of a large project through the development of software testing strategies, validation test plans, writing test cases and test scripts, coordinating test script execution, analyzing test results, and writing test reports for a complex system;
• be responsible for ensuring that all validation deliverables conform with accepted practices and ensure that testing is performed accurately, consistently, and on the project schedule;
• have had prior experience scheduling and leading meetings with core project team members to gain consensus on test script content, test script execution, and resolution to failures in order to meet test script objectives.
The ideal candidate will possess the following:
• 7-10 years' experience working with validated computer systems in Biotech or similar industry;
• previous experience working under 21CFR11 guidelines for computer system validation;
• excellent technical writing skills;
• experience developing testing strategies;
• experience writing and executing validation protocols and final reports;
• experience coordinating and working with departments who are executing and/or assisting in execution of protocols;
• excellent time management skills;
• the ability to plan, prioritize, and manage multiple tasks;
• a meticulous attention to detail;
• ability to set specific goals and work towards those goals with little or no guidance;
• takes initiative and has the ability to intuit the needs of the business analyst in an environment with a high degree of ambiguity;
• an eagerness to learn and continuously improve;
• people-oriented characteristics such as being a team player, having emotional intelligence and intuition;
• proficiency in Microsoft Office including Word, Excel, PowerPoint, Project, and Visio;
• knowledge of current validation guidelines and practices such as GAMP5 is a plus;
• knowledge of control frameworks such as ITIL is a plus;
• an understanding of agile software development is a plus;
• an understanding of cloud-based, multi-tenant technology is a plus.
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Thanks & Regards
Garry
HMG America LLC
PH: 732-645-2086
E:Gary@hmgamerica.com
http://www.hmgamerica.com/
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