Job Title : Project Manager
Location : Onsite, NY
Duration : 1+ Year
Job Summary:
Our client is developing an expansion project to increase production capacity and is seeking an experienced Project Engineer with a strong background in design for upstream and downstream biopharmaceutical processes. This Project Engineer will work closely with the client's Project Manager to evaluate the feasibility of installing a new area and drive project decisions from concept through preliminary design. The role requires extensive experience with capital projects, process design, equipment layout, and utility requirements, along with a strategic approach to improving process flow and production efficiency.
Key Responsibilities:
- Collaborate with the Project Manager to define the scope of the project, ensuring alignment with business objectives and capacity expansion needs.
- Conduct feasibility studies and evaluate all preliminary equipment lists and design requirements to determine if the project should move forward.
- Lead equipment design and process design activities, developing process flows and determining optimal movement from upstream to downstream processes, including purification.
- Develop and refine the equipment list, focusing on the utility and layout requirements for bioreactors, centrifuges, chromatography columns, ultrafiltration units, and media/buffer preparation.
- Create and optimize layouts to facilitate efficient operation transitions across rooms and ensure smooth production flows.
- Although not mandatory, prior experience with commissioning and qualification (C&Q) is highly desirable, as the Project Engineer will support C&Q activities in later project phases to validate equipment and process readiness.
- Assess utility demands for all equipment, ensuring designs meet capacity and reliability targets.
- Identify and address any potential bottlenecks or inefficiencies in the proposed layout and utility design.
- Develop and maintain detailed design documentation, ensuring all designs align with industry standards and regulatory requirements.
- Coordinate with cross-functional teams to ensure all documentation is current and meets GMP and biopharmaceutical compliance standards.
Qualifications:
- Experience:
- Minimum of 8 years of experience in project engineering with a strong emphasis on design within the biopharmaceutical industry.
- Extensive background in upstream and downstream bioprocesses, with demonstrated ability to take a project from early design through final process flow planning.
- Proven track record with capital projects, particularly with equipment design and process design.
- Technical Skills:
- Proficiency in developing and managing equipment lists, utility requirements, and process flows.
- Strong understanding of biopharmaceutical equipment such as bioreactors, centrifuges, chromatography columns, and ultrafiltration units.
- Familiarity with C&Q activities is preferred but not required.
- Educational Background:
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related field is preferred but not mandatory.
- Preferred Skills:
- Experience with regulatory and GMP standards for biopharmaceutical production.
- Strong analytical and problem-solving skills, with a proactive approach to design challenges.