Process Engineer

Katalyst CRO; Denver (CO); On-site; USD 120,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking an experienced engineering professional for a role in Denver, Colorado. You will support the start-up of a GMP large molecule biologics manufacturing facility, providing integrated engineering expertise to drive innovative solutions and ensure compliance with regulatory standards.

The ideal candidate will have a Bachelor's in Chemical or Mechanical Engineering, a minimum of 8 years in GMP facilities, and demonstrate leadership in process engineering and project management.

Qualifications

• Minimum of 8 years of process/plant engineering experience in GMP MFG large molecule biologics.
• Experience with green or brown field GMP facility start-up.
• Strong technical background in Process and Manufacturing engineering.

Responsibilities

• Interact with external partners to execute project plans as SME and process systems owner.
• Develop business-based technology solutions supporting CAPEX manufacturing projects.
• Provide technical leadership for technology transfers and new technology development.

Skills

Process Engineering

Project Management

GMP Standards

Analytical Skills

Education

Bachelor's Degree in Chemical or Mechanical Engineering

MS/MBA/Ph.D. or PE Certificate

Job description

Job Description

• Support the deployment of the MTO aspiration "to innovate to safely supply quality products and services competitively, faster, always."
• Responsible for providing advanced engineering design and start‑up of GMP large molecule biologics manufacturing facility systems and equipment. Provide integrated equipment, utility, and facility engineering expertise with an operational focus in support of technology transfer and manufacturing projects to support 'right first time' execution and start‑up.
• Drive innovative solutions in engineering support and process technology. Coordinate with Technical Operations platform to ensure project alignment with technology standards and engineering specifications for manufacturing technology.
• This is intended to be a general job description and should not be construed as all-inclusive.

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 detail and goal‑oriented teamwork, customer focus, and a 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 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 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

• Minimum of a Bachelor's or equivalent University Degree required in Chemical or Mechanical Engineering.
• MS/MBA/Ph.D. or 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, with strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs.