Sr. Director, Global Engineering

The Role:

Reporting to the SVP Facilities and Engineering, based at our Norwood, MA site,

the Senior Director of Global Engineering is a technical leadership position at the organization, one which has primary responsibility for leading the conceptual and detailed engineering of new manufacturing and R&D facilities worldwide. The candidate will lead a group of subject matters experts across multiple disciplines including Plasmid, mRNA Drug Substance, mRNA Drug Product Manufacturing, Plant and Clean Utilities including HVAC. The position requires broad engineering knowledge of the Drug Substance and Drug Product Manufacturing Technologies. It also requires strong project management skills with the ability to keep multiple projects on their timelines and on budgets in a fast based and demanding environment. Candidate must have a strong process approach and an eye toward continuous improvement with as are strong organizational skills and written and verbal communication skills.
 

Candidate should have knowledge of regulatory and performance requirements for pharmaceutical manufacturing facilities. Candidate will establish and lead a local team of project delivery and manufacturing support resources (Process Engineering for Drug Substance and Drug product Manufacturing, Plant and GMP Utilities) at remote locations for project execution. Candidate would be responsible for overall project delivery up to Operational Readiness milestone.

Travel to support global manufacturing expansion could be up to 25% at critical project phases.

Here’s What You Will Do:

• Partners with the Capital Project Delivery and Project Control Team in the delivery of manufacturing, Office, and R&D facilities worldwide.

• Lead combines technical team of mRNA Drug Substance process engineer, facilities and utilities engineers, process improvement, Sterile Filling, Automatic Inspection and Packaging, on capital projects delivery in compliance with regulatory standards.

• Ensure good engineering practices are followed through for the performance of control and coordination activities on all process phases (planning, development, approval, and implementation); integration and synergies between Global and local requirements; ensure maintenance and operations best practices and guidelines sharing across Moderna’s mfg. network

• Strategic and tactical leadership of design, construction, commissioning, qualification (if applicable) and operational readiness workstreams for capital project portfolio.

• Partner with MS&T (Manufacturing Sciences & Technology) (Manufacturing Sciences & Technology) and Technical Development organizations in the development of novel manufacturing technologies around Moderna’s mRNA platform.

• Provide input to short- and long-term capital planning

• Own and drive energy reduction program for the site through conservation, new equipment, and technologies to reduce overall costs and drive sustainability

• Working closely with procurement, direct the bid evaluation and contract award processes and coordinate the negotiation of contracts with engineering firms, process equipment vendors, skid, and oversight of equipment acquisition activities

• Provide leadership in the management of external design team professionals from project inception through completion and ensure they produce thorough and accurate drawings which comply with all established standards

• Ensure review of all construction drawing documents and specifications, coordinating necessary reviews with business unit representatives and regulatory authorities

• Coordinate with internal stakeholders to insure efficient and timely turnover of space for effective operations, including a maintenance and calibration package

• Oversee relationship with the local municipality authorities for project permitting and other business related to site improvements

• Recruit and hire top engineering talent

• Grow and mentor process engineering teams at manufacturing sites

• Work with the Engineering leadership to scale the engineering organization as required by Moderna’s growth.

Here’s What You Will Bring to the Table:

• At least 20 years of relevant experience working with engineering project delivery, construction capital projects or 15+ years with master's degree in engineering, preferably in a pharmaceutical/FDA-regulated work environment.

• A professional and advanced degree in Engineering. Chemical Engineering background is preferred.

• 10 or more years’ experience leading others on project teams, interfacing and influencing at executive levels.

• Substantial operational engineering experience

• Broad knowledge of engineering asp