CSV Lead/ Computer System Validation at Philadelphia, Pennsylvania

CSV Lead/ Computer System Validation Lead

Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry. We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In today's world, it's never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services.

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.

At Compli, we are about innovative and intelligent people who want to solve problems. We're known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology. At Compli, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.