Process Engineer
Katalyst CRO · Huntsville, AL · 1 mo ago
On-siteEngineeringContract
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.
- Demonstrate detail and goal-oriented approach, teamwork, customer-focus, and 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.
- Drive 'right first time' start up and execution of manufacturing technology.
- 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 into business solutions.
- Provide technical leadership of multi-functional teams on many projects/process improvements and resolve 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.
Requirements
- A minimum of a Bachelor's or equivalent University Degree required in Chemical or Mechanical Engineering.
- MS/MBA/Ph.D. PE Certificate preferred.
- 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.