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US-NJ, Computer Validation -Project Manager/Sr. Engineer/Engineer Job# WRE/MZL/STO/2392HS

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Q. To apply for this position, click here: http://www.medzilla.com/jobs/wj23018.htm US-NJ, Computer Validation -Project Manager/Sr. Engineer/Engineer Job# WRE/MZL/STO/2392HS We're driven by teamwork. What drives you? The spirit of a small company. The resources of a large one. You'll find them both at Schering-Plough Pharmaceuticals. We're the manufacturers of an expanding line of life enhancing pharmaceuticals including such well-known brand names as CLARITIN and INTRON A. Here you'll experience a familial, entrepreneurial environment that fosters camaraderie and collaboration. And you'll benefit from the vast resources of a global leader. We now have the following exceptional opportunity available in our Technical Operations division at our Kenilworth location in New Jersey. Computer Validation -Project Manager/Sr. Engineer/Engineer Job description: There are 3 levels of job titles supporting this position: Project Manager, Sr. Engineer, Engineer. Incumbent's responsibilities will vary dependant on level of expertise and support. Provides expert consultation and/or technical support to manufacturing sites for in-line products and processes. Areas of expertise may include but are not limited to validation of manufacturing, packaging, information, facility, quality and laboratory computer and automation systems. Will lead or work on assigned projects from the point of technology transfer of new products and processes in conjunction with other departments. Responsible for providing strategic and/or tactical direction and guidance for project teams implementing computer validation activities for new and existing GMP systems. The Technical Manager will provide guidance on the development of appropriate testing strategies and input on technology development activities to ensure that the principles of validation are captured and maintained throughout the System Development lifecycle. Will oversee or participate in the generation of validation study documentation such as System Validation Plans, protocols, reports and schedules. Provide support to the manufacturing sites during pre-approval and general GMP inspections. Establish or participate in policies, standards, templates, and recommended procedures in areas of Computer Validation. *Areas of experience may include validation of manufacturing, packaging, information, facility, quality and laboratory computer automation systems. Requirements: Minimum 5 to 9 years experience in validation or in technical capacities which support validation initiatives, with demonstrated validation expertise in one or more areas as listed in job description B.S. in engineering or pharmaceutics-related field Demonstrated knowledge of GMPs and regulatory guidelines Strong project management skills Strong communication skills Strong technical-problem resolution skills Thorough working knowledge of PLCs and manufacturing systems At the Manager level, incumbent will be proficient in leadership of complex projects and teams We offer an excellent compensation program including competitive salary, profit sharing, 401(k), and health and wellness programs. For more information and to apply online search jobs at www.whatdrivesyou.com or mail your resume, referencing job code WRE/MZL/STO/2392HS , to: Schering-Plough c/o Resume Processing, P.O. Box 549248, Suite 187, Waltham, MA 02454-0248. Relocation may be available. No agencies please - direct candidates only. By responding to this posting you may be considered for other potential opportunities throughout the Schering-Plough organization. If a potential match exists, you will be notified. An equal opportunity employer.

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