Job Description
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.
Responsibilities :
- 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 the identification and communication of the root causes of losses in the operation of production equipment and processes.
- 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
Requirements :
- Bachelor’s degree in chemical engineering, biochemical engineering, mechanical engineering, or a related field.
- At least two years of aseptic pharmaceutical manufacturing/engineering experience.
- In depth understanding and application of cGMP principles, concepts, practices and standards.
- Must have at least one year of Blow/Fill/Seal sterile processing experience and understand the operating principles of isolators and gloveboxes.
- Equipment commissioning and/or qualification experience needed.
- Process Safety Management understanding needed.
- 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.
- Must be willing to travel (95%) regionally and/or nationally throughout the U.S.A.
- Maintenance and Reliability Engineering experience is a plus
- All other duties as assigned.
It’s more than just a job…
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.
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