Process Engineer

Katalyst CRO; Denver (CO); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking a seasoned Process Engineer to lead the design and startup of GMP large molecule biologics facility systems, equipment, and utilities with a focus on right-first-time execution.

The role requires coordinating with operations, quality, and engineering teams to ensure technology standards are met and regulatory requirements are satisfied.

Qualifications

• Bachelor's in Chemical or Mechanical Engineering (or equivalent).
• Strong GMP knowledge for large molecule biologics facilities.
• Experience with process/plant engineering in GMP manufacturing.

Responsibilities

• Interact with external partners to develop and execute project plans as SME and process systems owner.
• Serve as Process Engineering Expert to support technology transfer and startup of GMP facilities.
• Provide leadership for technology transfers and new technology development projects.
• Identify manufacturing challenges and translate business needs into engineering solutions.
• Lead multi-functional teams on projects and resolve inter-functional issues.
• Collaborate with manufacturing, quality, and engineering to define project needs and priorities.

Skills

Process engineering

GMP knowledge

Biologics manufacturing

Regulatory compliance

Education

Bachelor's in Chemical or Mechanical Engineering

MS/MBA/PhD PE Certificate preferred

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.

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 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.

Requirements:

• 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.