CSV Lead/ Computer System Validation Lead

About the role

Supporting Validation of Computer systems in support of a newly constructed drug manufacturing facility.
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.

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.
• 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 vendors quotations, clarifications, and perform technical bid analysis. Review vendors 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).
• Prior experience in a pharmaceutical / biotech manufacturing environment
• Prior experience with Current Good Manufacturing Practices and other applicable regulations

Qualifications

• Kneat experience preferred.
• Excellent client-facing relationship building skills.
• Excellent written and verbal communication skills.
• Excellent math and problem-solving skills.
• Ability 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

Local to the Marietta, PA Metropolitan area. No per diem or travel assistance currently offered.

Pay

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Skills

Not specified

Benefits

Not specified

Pay

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Schedule

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