Process Engineer

Katalyst CRO; Bridgeport (CT); On-site; USD 100,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a seasoned Process Engineering Expert to support the start-up and execution of a GMP large molecule biologics manufacturing facility. Candidates should possess a strong technical background and be well-versed in regulatory requirements and project management.

The position requires collaboration with multi-functional teams and external partners, ensuring alignment with manufacturing needs and engineering specifications. A Bachelor's degree in an engineering discipline and at least eight years of relevant experience are essential for this role.

Qualifications

• Bachelor's degree in Chemical or Mechanical Engineering required.
• 8+ years of experience in GMP manufacturing for large molecule biologics.
• Experience in GMP facility start-up and process systems.

Responsibilities

• Drive project plans as SME and process systems owner.
• Provide technical leadership for technology transfers.
• Collaborate with internal teams to define project needs.

Skills

Process Engineering

GMP Compliance

Project Management

Analytical Skills

Education

Bachelor's 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.