Validation Analyst

Biotechnology and Pharmaceutical Validation Analyst Job Description:Support operation through the Global Systems support structure. Specific areas of responsibility are in the area of SAP validation within the areas of: Operations, Finance, Supply Change, Sales & Marketing and Quality Assurance. The overall objective is to provide global solutions to meet the business and regulatory requirements of Boston Scientific.Duties and Responsibilities: Work with GSP business units to apply the QMAC policy for SAP software system Assist users in understanding the fundamentals of software validation Conduct validation per QMAC on new or legacy systems Oversee the Quality plan and other validation documentation Define the software validation activities to be conducted by the project Complete assigned tasks within the scope of the work plan and under the supervision of the Validation Manager Learn necessary analytical tools, engagement tools, and technologies/systems needed to complete work Maintain awareness of business needs, expectations, and level of satisfaction; communicates areas of concern to validation/project manager Common Responsibilities: Produce quality project deliverables (including Validation Plans, IQ/OQ/PQ reports, testing reports and summary reports) in support of BSC projects Develop knowledge of methodology, application areas, writing, and presentation skills Adhere to the confidentiality, protection of proprietary information, and other legal responsibilities Be available to travel to other BSC sitesMinimum Education & Experience:3 - 5 years experience with GCP, GLP, GMP, 21 CFR Part 11 & 21 CFR Part 820Familiarity with SDLC and software applications, including SAP, PDM a plusEffective use of MS Office productsAbility to work independently and on a teamHands on experience in computer systems is preferredBachelor’s degreeGood communication and interpersonal skills.Specific process knowledge and related experienceKnowledge of related business applications preferredSelf starter with strong, proactive work ethicProject Management skills a plusTravel will not be part of the normal activities < 5%Minimum Education Required: BachelorYears of Experience Required: 3-5 YearsExpected Travel Time: About 25% Please visit us online at www.bostonscientific.com for more information.