Bachelor's degree in Chemical or Mechanical Engineering required; advanced degrees preferred
Eight years of experience in process/plant engineering in GMP large molecule biologics facilities
Experience in green or brown field GMP facility start-up
Strong technical background in Process and Manufacturing engineering
Proficient in synthesizing business needs and engineering requirements
Responsibilities
Support the deployment of the MTO aspiration by ensuring quality product supply and competitive services
Provide engineering design and start-up support for GMP biologics manufacturing systems
Drive innovative engineering solutions and coordinate with Technical Operations for project alignment
Interact extensively with external partners to execute project plans as subject matter expert
Lead technical efforts for technology transfers and new technology development
Collaborate with internal teams to establish project standards and priorities
Demonstrate strong communication, leadership, and conflict management skills
Benefits
Opportunities for professional development and advancement
Collaborative working environment
Exposure to cutting-edge technology in biologics manufacturing
Engagement in challenging projects with significant impact
Access to a diverse network of partners and industry experts
Full 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 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.
