Hello Professionals, Hope you are doing well.
Job Title: CSV Project Manager Job Location: Caguas, Puerto Rico Long Term Contract Mandatory Skills: . Experience with regulated environments (FDA, OSHA, EPA, etc.). . Understanding and awareness of industry/regulatory trends for verification/validation. . Strong process equipment knowledge - cell culture, fermentation, purification, filling and packaging. . Strong process automation knowledge - understanding of automation infrastructure, current technologies, and automation project execution / verification. Preferred Skills: . Experience in Manufacturing industry is an added advantage. . Experience implementing risk-based verification on major GMP process equipment/automation projects, including validation protocol development and execution. . Experience in developing SOPs and delivering training. . String process equipment knowledge. Job Roles/Responsibilities: . Demonstrate functional understanding of source system to be included in manufacturing systems and create robust and scalable design. . Perform manufacturing computer systems validation including Gap assessment, Risk assessment, and process SOPs, user requirements. . Conduct requirements gathering and Business Analysis related to Asset and Data Warehousing efforts. . Support the upgrade of manufacturing and packaging equipment and define processes for equipment use. . Perform IQ and OQ for line and site configurations and manage change control for the project. . Provide all architecture efforts across the Enterprise Asset Management application, including management and communication of related approach, policies and strategies. . Provide Asset Management Systems consulting related to Maximo system. . Define and develop the exception handling strategies for the sensitive Quality & Regulatory, Compliance and business critical data structures. . Define and implement Workflow, Configuration and Data Structure, per Business Requirements. . Analyze inputs and devise strategy based on best practices and future supportability. . Assist team members and troubleshooting, diagnosing and resolving complex, Maximo, problems to ensure high performance and minimal disruption of critical systems. Thanks & Regards Deependra Kumar IDC Technologies, Inc Work: 408-882-6922 Mailto: <mailto:[email protected]> [email protected] 920 Hillview Court, Suite 250, Milpitas, CA 95035 _____________________________________ Empowering Technologies Services Remote Services | IT Services | BPO | IT Consulting | Staffing Solutions | _____________________________________ -- You received this message because you are subscribed to "rtc-linux". Membership options at http://groups.google.com/group/rtc-linux . Please read http://groups.google.com/group/rtc-linux/web/checklist before submitting a driver. --- You received this message because you are subscribed to the Google Groups "rtc-linux" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. For more options, visit https://groups.google.com/d/optout.
