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Founded in 1811, Massachusetts General Hospital is the thirdoldest general hospital in the country, and the oldest and largest in New England. The 907bed ...
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Founded in 1811, Massachusetts General Hospital is the thirdoldest general hospital in the country, and the oldest and largest in New England. The 907bed ...
For your reference, we have included the original job posting below.
Senior I.T. Compliance Engineer
Job Number:
22448654
Company Name:
Genzyme
Job Location:
Framingham, MA US
Job Category:
Healthcare & Medical
Senior I.T. Compliance Engineer
Title: Senior I.T. Compliance Engineer Location: Massachusetts-Framingham Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzyme's people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortune's list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzyme's local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success. Senior I.T. Compliance Engineer Senior I.T. Compliance Engineer for 74 NYAReporting to the Site Computer Validation Manager, this position plays a key role in the delivery of IT infrastructure for applications and systems supporting Genzyme's new cell culture manufacturing facility in Framingham, MA. Job Description and ResponsibilitiesThis position will entail responsibility for the organization and application of IT compliance activities relating to the IT infrastructure to be used in the cell culture facility of 74 NYA. The responsibilities include:. Support and leadership in all compliance activities for the delivery of qualified IT infrastructure platforms and support of validated applications including, but not limited to new installations of MES, data historian and process control systems. . Development of GMP documentation for implementing, testing, and operation of IT networks and systems infrastructure in support of validated software applications:o Generate, review & approve as required IT infrastructure related qualification documentation, including qualification plans, requirements & design specifications, requirements traceability matrix, risk assessments, qualification test protocols, software & document logs and reportso Identify, assess and communicate all deviations or discrepancies encountered during qualification activities, complete/support agreed corrective or remediation actions in a GMP environment.o Generate/Update infrastructure templates for diagrams, procedures & master inventory listing / configuration management database, and asset management system as required during infrastructure installation & qualification. . Providing technical expertise in the installation and testing of computer equipment adhering to project timelines while following compliance requirements . Coordinating these activities with managers of technical groups and computer systems owners. . Maintaining a focus on IT Compliance best practice ic requirements:. Experience working in a fast-paced and innovative environment. Basic Qualifications: Bachelor's Degree in information technology or related fields. Minimum of 9 years of demonstrated experience in IT infrastructure compliance/validation. Project management experience. Proven track record working in a regulated environment in the role of IT Quality / Compliance Specialist/Engineer under FDA, GAMP and other regulatory requirements (SOX). Expertise in development and review of documentation for Qualification, Disaster Recovery, Network Management, Change Control.. Experience in management of external resources for support of systems (SLA/OLA).. Excellent communication, organizational & analytical skills; ability to communicate complex issues within a multi-disciplinary teamPreferred requirements:. Experience in a project oriented, SLA based 24x7 manufacturing environment with the ability to work in a matrixed environment.. Excellent communication, organizational & analytical skills with the ability to communicate complex issues within a multi-disciplinary team.
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