PASX Engineer at Framingham, Massachusetts, USA |
Email: [email protected] |
From: Cauvery Priyadarshini, Vyze Inc. [email protected] Reply to: [email protected] Hi, This is Cauvery from Vyze Inc. Please find the below position , if youre comfortable with the JD kindly revert me bacK . Job Description - Job Title: PASX Engineer Visa: No H1B, CPT Location: Framingham, MA (Hybrid) MOI: Skype Responsibilities include: Problem Solving: o Provide technical solutions to a wide range of difficult problems through individual efforts as well as strategic leveraging of outsourced personnel. Solutions are imaginative, thorough, practical, and consistent with organization objectives. Production: o Responsible for ensuring MES and potentially other manufacturing related computerized systems are available to support Operations Schedule Adherence requirements. o Managing small to medium projects related to MES and ensuring that the appropriate controls, approvals, and validation requirements are implemented. Training /Deviations /Compliance: o Complying with Sanofi requirements for training, maintaining training at or above 95% on time. o Utilizing quality systems to measure, analyze, and improve team performance. o Participate in staff meetings, providing updates of department activities and project statuses. o Ensuring that Process, Equipment and MES documentation is compliant and inspection ready. o Participating in inspections conducted by external regulators. o Partnering with direct and indirect management chain to ensure the following: Designing Department Training Plan and managing execution. Ensuring Inspection Readiness of assigned areas. Overseeing completion of investigations and deviations. Safety o Complying with requirements from Sanofi's Safety Program including Health and Safety regulations and OSHA requirements. Continuous Improvement: o Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner. o Identifying opportunities to improve manufacturing processes and practices. o Ensuring all manufacturing management tools/systems and documentation (SOPs, MBR's, OJTs) is accurate. o Partnering with Manufacturing to troubleshoot and drive resolution of process issues and proactively driving projects to improve manufacturing process. o Partnering with Operational Excellence to drive business process improvements through Kaizens, Kanban, 5S and VSM in their area of responsibility. o Ensuring that internal customers and suppliers are aligned with the solutions and services of the department. Basic Qualifications: Bachelors degree in Engineering, Science and 1 to 2 years relevant work experience or 5 years of relevant work experience. 1 year of electronic batch record editing experience with MES Systems Koerber/Werum PASX Direct experience with regulated environments (i.e. cGMP, OSHA, EPA). Demonstrated knowledge of validation requirements for control systems in CGMP and/or ASTM environments. Preferred Qualifications: Masters with 1+ years of relevant work experience. MES Koerber/Werum PAS-X batch record editing experience. Experience in OSI PI system maintenance and configuration activities Experience with DCS systems Experienced in establishment of safe practices in a cGMP environment. Proficient working with computer programs/applications such as Windows, VBA, MS Word, Excel, Access, etc. Thanks and Regards. Cauvery Priyadarshini US IT Recruiter Vyze INC (An E- VerifiedCompany) Email: [email protected] 25179 Methley Plum Place, Aldie, VA 20105 www.vyzeinc.com Disclaimer: This communication, along with any documents, files or attachments, is intended only for the use of the addressee and may contain confidential information. If you are not the intended recipient, you are hereby notified that any dissemination, distribution or copying of any information contained in or attached to this communication is strictly prohibited, To remove your email address permanently from future mailings, please send REMOVE to [email protected] . Keywords: information technology microsoft Massachusetts Virginia |
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Wed Aug 30 06:14:00 UTC 2023 |