What are the responsibilities and job description for the Project Process Engineer position at QCS Staffing?
Project Process Engineer - RTP, North Carolina - 12 Months Contract
Our client, a globally recognized pioneer in Biotechnology, are recruiting for the position of Project Process Engineer. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. The project at hand is for the construction of a new build biomanufacturing plant based located on the East Coast.
Essential duties and responsibilities for this role include, but are not limited to, the following:
Our client, a globally recognized pioneer in Biotechnology, are recruiting for the position of Project Process Engineer. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. The project at hand is for the construction of a new build biomanufacturing plant based located on the East Coast.
Essential duties and responsibilities for this role include, but are not limited to, the following:
- Lead and manage the process engineering scope for greenfield drug substance manufacturing lines.
- Work closely with cross-functional teams, including design, equipment, and construction, to ensure timely and effective execution.
- Act as the technical Subject Matter Expert (SME) for upstream, downstream, purification, and clean utilities.
- Oversee the design and specifications of process equipment, ensuring they meet project requirements.
- Coordinate Factory Acceptance Tests (FATs) for equipment.
- Provide technical support and expertise throughout the project lifecycle, from design to start-up and handover.
- Review and recommend improvements to processes and procedures to ensure optimal efficiency and compliance with industry standards.
- Ensure the integration of process systems and equipment aligns with client's quality standards and regulatory requirements.
- Support commissioning and qualification efforts for process equipment.
- Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or related discipline.
- Extensive experience in process engineering, with a strong focus on drug substance biologics projects. Experience with a solid background may also be considered.
- In-depth knowledge of drug substance manufacturing processes, including upstream, downstream, purification, and clean utilities.
- Proven experience in the design, specification, and FATs for process equipment.
- Strong technical expertise in drug substance equipment (reference engineering booklet for required equipment).
- Familiarity with GMP regulations, safety standards, and industry best practices.
- Excellent problem-solving, communication, and team collaboration skills.
- Ability to work in a fast-paced, dynamic environment and manage multiple priorities.
