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CSV Project Manager
Ref No.: 19-00031
Location: Caguas, Puerto Rico
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.
  • Provide periodic Progress and Status Reports.
for any queries contact Raj at 760 307 4256.