Bachelor's degree in Chemical or Mechanical Engineering; MS/MBA/Ph.D. and PE Certificate preferred.
8+ years of process/plant engineering experience in GMP large molecule biologics manufacturing facilities.
Experience in green or brown field GMP facility start-up.
Strong background in Process and Manufacturing engineering with analytical skills.
Thorough understanding of GMPs and regulatory requirements.
Responsibilities
Interact extensively with external partners to develop and execute project plans as a Subject Matter Expert.
Serve as Process Engineering Expert to provide integrated engineering expertise for strategic CAPEX manufacturing projects.
Lead technology transfers and new technology development projects to ensure process fit.
Analyze manufacturing challenges and synthesize business and engineering needs into solutions.
Provide leadership for multi-functional teams to address process improvements and resolve issues.
Collaborate with internal stakeholders to define project priorities and recruit team members.
Possess effective communication and leadership skills, with a focus on conflict and risk management.
Benefits
Support for innovative projects in a forward-thinking environment.
Opportunity to lead significant technology development initiatives.
Engagement with cross-functional teams and build valuable external partnerships.
Focus on 'right first time' execution, which highlights quality and efficiency.
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.
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.
