Director, Engineering Projects

The Role:

Reporting to the SVP Facilities, Engineering and Real Estate, based at our Norwood, MA site, the Director of Engineering Projects is a technical leadership position at the organization, one which has primary responsibility for the conceptualization, design and development, validation and support of new manufacturing and R&D facilities worldwide. 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 resources (Construction Manager, Project Controls, Project Engineering, CQV Lead) 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% and up to 50% at critical project phases.

Here’s What You’ll Do:

• Lead combines technical team of process engineer, facilities and utilities engineers, process improvement, Sterile Filling, Automatic Inspection and Packaging, capital projects delivery, 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 as well as tactical leadership of design, construction, commissioning, qualification (if applicable) and operational readiness workstreams for capital project portfolio.

• Partner with MS&T 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’ll Bring to the Table:

• At least 18 years of relevant experience working with construction capital projects or 15+ years with MS, preferably in a pharmaceutical/FDA-regulated work environment.

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

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

• Substantial operational engineering experience

• Broad knowledge of engineering aspects associated with pharmaceutical drug substance and drug product manufacturing

• Knowledge of Quality Assurance (QA) and Environmental, Health & Safety (EHS) standards

• Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP)

• Experienced working on all aspects of capital projects, including budgeting, design, construction, validation, start-up and ongoing operations will be a plus.