Job: CSV Lead/ Computer System Validation Lead
Location: Marietta, PA
What You'll Do:
- 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.
- 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.
What You'll Bring:
- 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.
- 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
Travel: Local to the Marietta, PA Metropolitan area. No per diem or travel assistance currently offered.
*This role is not open to C2C staffing.
