Csv Project Manager

Mandatory Skills- Experience with regulated environments (FDA, OSHA, EPA, etc.). Understanding and awareness of industryregulatory trends for verificationvalidation. 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 equipmentautomation projects, including validation protocol development and execution. Experience in developing SOPs and delivering training. String process equipment knowledge. Job RolesResponsibilities- 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. Provide periodic Progress and Status Reports. for any queries contact Raj at 760 307 4256.