Note: The job is a remote job and is open to candidates in USA. Katalyst CRO is a company focused on innovative solutions in biologics manufacturing. The Process Engineer role involves providing advanced engineering design and support for GMP large molecule biologics manufacturing facilities, ensuring effective technology transfer and project execution.
Responsibilities
- Extensive interaction with external partners (A&E, construction firms, equipment vendors) to develop, organize and execute project plans as SME and process systems owner. The incumbent should demonstrate the following: detail and goal oriented, teamwork, customer-focus, thorough understanding of GMPs and regulatory requirements
- Serve as Process Engineering Expert to develop business based technology solutions and provide integrated equipment, utility, and facility engineering expertise with an operational focus to support execution of strategic and key CAPEX manufacturing projects, driving 'right first time' start up and execution
- Provide strong technical leadership and expertise for technology transfers and new technology development projects to ensure process fit to plant methodology and practices
- Explore and understand Technology and Manufacturing challenges and synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions
- Provide technical leadership of multi-functional teams on many projects/ process improvements and resolves inter-functional issues
- High degree of collaboration with internal (manufacturing, quality, engineering) to develop standards and define project needs and priorities; as well as recruiting project team members
- The incumbent must also have a thorough understanding of business requirements, effective communication skills, leadership, and interdependent partnering, conflict and risk management
Skills
- Minimum of a Bachelor's or equivalent University Degree required in Chemical or Mechanical Engineering
- A minimum of eight (8) years of process/plant engineering experience in GMP MFG large molecule biologics facilities
- Experience in green or brown field GMP MFG facility start-up including process systems, automation, utilities, facilities and operations
- Strong technical background in Process and Manufacturing engineering, strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs
- MS/MBA/Ph.D. PE Certificate
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