Process Engineer 3

Katalyst CRO; Wilson (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Process Engineering Expert located in Wilson, NC. The role involves extensive interaction with external partners and project execution as a subject matter expert. Key responsibilities include technical leadership for technology transfers and collaboration with internal teams to address project needs.

Successful candidates will have a Bachelor's degree in Chemical or Mechanical Engineering and at least three years of GMP manufacturing experience, alongside strong analytical and collaboration skills. This position includes some domestic travel.

Qualifications

• Minimum of a Bachelor's or equivalent University Degree required in Chemical or Mechanical Engineering.
• A minimum of three years of process/plant engineering experience in GMP manufacturing large molecule biologics facilities.
• Experience in GMP manufacturing facility start-up including process systems and operations.

Responsibilities

• Interact with external partners to develop and execute project plans as SME.
• Provide technical leadership for technology transfers and new development projects.
• Collaborate with internal teams to develop standards and define project needs.

Skills

GMP understanding

Process engineering

Collaboration

Strong analytical skills

Education

Bachelor's degree in Chemical or Mechanical Engineering

MS/MBA/Ph.D. preferred

Job description

Job Description

• This position is to be located in Wilson, NC with domestic travel once a year.
• 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 (3) 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.