Hi, Three Different Position's for Validation Consultant......! Please let me know if you have any, *plaese call to discuss at 201-257-5081 x 293*
Title : Validation Specialist Location : Framingham, MA Duration : 12 Months Contract Validation Specialist: Perform a variety of tasks necessary to evaluate equipment performance and quality in accordance with company standards (SOP's) and in compliance with current FDA and international regulatory requirements (i.e., GLP and CGMP). You will work independently with minimal supervision and direction. Responsibilities include the development and execution of validation protocols; troubleshooting and evaluation of test results; and the development of validation reports. You will also provide input to the technical composition of operating documentation. Qualifications Basic Qualifications: Associates degree and 2-4 years experience working in a pharmaceutical environment. Preferred Qualifications: Bachelor's degree and knowledge of temperature mapping, validation/qualification of autoclave, use of a Kaye Validator, and installation and operation qualification of analytical equipment. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ *Validation Specialist Technician* perform a variety of tasks and duties in support of Operations and Quality Systems for cell therapies products. The qualified individual will work under direct guidance to aply GMP validation principles in accomplishing project goals. The individual will execute predefined installation and operational qualification protocols and may be responsible for editing or creating protocols. These protocols will be applied to systems including but not limited to incubators, autoclaves, depyrogenation ovens, cryostorage vessels, and other temperature-controlled chambers in a cleanroom environment. In addition, the qualified individual will review all daily metrology records, coordinate and monitor the activities of metrology and calibration vendors, and share in the administrative upkeep associated with a cGMP Validation Department. Qualifications Basic Qualifications: · Associates Degree and 6 months experience working in GMP regulated environment, or Bachelor's Degree and 0 - 6 months experience. · Proficiency with Microsoft Word and Excel applications required. · Working proficiency or aptitude in basic mathematical / statistical techniques required. Preferred Qualifications: · Experience with thermal data acquisition systems (Kaye Validator, ValProbes) preferred. · Experience with other Microsoft productivity applications (Access, Powerpoint, Project) preferred. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ *Validation Engineer III* work in an individual contributor role in the validation, qualification and requalification of equipment and processes used in the manufacture of biopharmaceutical products. Equipment will include laboratory equipment, fill finish equipment, sterilizers and biopharmaceutical equipment used at Genzyme sites or at CMO sites. Processes may include cold chain, fill finish, cleaning and related biopharmaceutical processes used at Genzyme sites or CMO sites. The individual will write, execute and review validation protocols and reports. Basic Qualifications: Bachelor's Degree in Science or Engineering and 7 or more years of hands on validation experience. Alternatively an Associates Degree with 9 years experience is acceptable. Must be familiar with applicable US and worldwide regulatory requirements used in the biotechnology industry. Experience with Kaye Validators is required. The individual must be able to travel at least 6 weeks per year, to provide support at other Genzyme or CMO sites. Preferred Experience: Validation experience in cleaning validation and fill finish validation is preferred. Experience with MS Word, Excel and Project. Thanks Davis Johnson 201-257-5081 x 293 [email protected] -- You received this message because you are subscribed to the Google Groups "SAP ABAP" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. For more options, visit this group at http://groups.google.com/group/sap-abap?hl=en.
