What are the responsibilities and job description for the Project Process Engineer position at QCS Staffing?
Project Process Engineer - RTP, North Carolina
We are seeking a highly skilled Project Process Engineer to join our client, a pioneering leader in Biotechnology. With a focus on high unmet medical need and leveraging expertise for solutions, this is an opportunity to be part of a global mission improving lives affected by disease and illness.
The project involves the construction of a new biomanufacturing plant located on the East Coast. Key responsibilities include:
Desirable Qualifications:
This role requires a unique blend of technical expertise, leadership skills, and ability to work effectively in a team environment.
We are seeking a highly skilled Project Process Engineer to join our client, a pioneering leader in Biotechnology. With a focus on high unmet medical need and leveraging expertise for solutions, this is an opportunity to be part of a global mission improving lives affected by disease and illness.
The project involves the construction of a new biomanufacturing plant located on the East Coast. Key responsibilities include:
- Leading process engineering scope for greenfield drug substance manufacturing lines.
- Collaborating with cross-functional teams for timely and effective execution.
- Serving as technical Subject Matter Expert (SME) for upstream, downstream, purification, and clean utilities.
- Overseeing process equipment design and specifications, ensuring project requirements are met.
- Coordinating Factory Acceptance Tests (FATs) for equipment.
- Providing technical support throughout the project lifecycle from design to start-up and handover.
- Reviewing and recommending improvements to processes and procedures for optimal efficiency and compliance with industry standards.
- Ensuring integration of process systems and equipment aligns with quality standards and regulatory requirements.
- Supporting commissioning and qualification efforts for process equipment.
Desirable Qualifications:
- 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.
- In-depth knowledge of drug substance manufacturing processes including upstream, downstream, purification, and clean utilities.
- Proven experience in design, specification, and FATs for process equipment.
- Strong technical expertise in drug substance 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.
This role requires a unique blend of technical expertise, leadership skills, and ability to work effectively in a team environment.
