CSV Lead/ Computer System Validation Lead

About the role

Supporting Validation of Computer systems in support of a newly constructed drug manufacturing facility. Position will serve a key role in delivery to accommodate the exit of the existing facility.

Responsibilities

• Lead the development and execution of CSV documents
• Provide project / process engineering support for capital project delivery projects
• Ensure planned progress with respect to the engineering deliverables for projects, process engineering planning & scheduling, preparation of progress reports, manpower & resource forecasts, and utilize resources effectively & efficiently
• Provide process design & detailed engineering including performing process simulations, design calculations, process optimization, sizing & selection of equipment for projects
• Prepare various engineering deliverables (drawings & documents) such as process flow diagrams, P & I diagram, process datasheets, equipment specifications, cause & effect diagrams, control philosophies, shutdown philosophies, and HAZOP studies & reports
• Facilitates and executes engineering change control documentation
• Provide the necessary process engineering inputs for capex projects to the other disciplines and other departments
• Prepare and issue RFIs, evaluate vendor’s quotations, clarifications, and perform technical bid analysis
• Review vendor’s documents, drawings, datasheets, specifications and calculations
• Supports construction and trade groups with site safety programs and assist in safety documentation
• Other duties as assigned

Requirements

• BS in related engineering field (Chemical / Mechanical / Architectural / Electrical) (required)
• 10 to 15 years of experience in support of project or production, processes and process optimization (required) // process engineering including process design (if possible)
• Prepare process engineering deliverables for investment projects (e.g., PFDs, Equipment Specifications), experience is preferred but not required
• Act in assigned roles within capital investment projects (e.g., Project /Process Engineer), experience is preferred but not required
• Kneat experience preferred
• Prior experience in a pharmaceutical / biotech manufacturing environment
• Prior experience with Current Good Manufacturing Practices and other applicable regulations
• Excellent client-facing relationship building skills
• Excellent written and verbal communication skills
• Excellent math and problem-solving skills
• Able to work independently or in collaboration with others
• Solid organizational skills including attention to detail and multitasking skills
• Proficient in MS Excel, MS Word, MS Project, MS PowerPoint, MS Access

Benefits

No per diem or travel assistance currently offered. This role is not open to C2C staffing.

Pay

N/A

Schedule

N/A