The Role:

This position will have accountability for the Maintenance, Metrology, Facility and Engineering groups serving ElevateBio’s BaseCamp Waltham site. The position is responsible for all site GMP and non-GMP operational procedures and programs aligned with existing policies. The position will work closely with the other user groups and management in support of meeting project timelines and goals, including the Central Engineering Services team and other BaseCamp sites

Here’s What You’ll Do:

• Be a member of the BaseCamp Waltham Site Leadership Team (WLT) representing Facilities & Engineering. The WLT is responsible for setting site strategy, goals, and overseeing day-to-day operations and performance.
• Be a champion of ElevateBio’s strong commitment to employee health and safety and environmental sustainability. Align with the site EHS team to drive key site programs, such as area GEMBA.
• Contribute to the site’s overall growth strategy, develop plant and equipment investment plans and oversee the departmental budget and headcount.
• Support the development and execution of facility capital expenditure budget.
• Direct the Process & Validation Engineering group(s) and oversee asset life-cycle program.
• As part of lifecycle maintenance of the facility, review and approve plans and submittals related to HVAC, electrical, plumbing, clean utilities, clean rooms, etc. Act as subject matter expert for all site systems and equipment.
• Partner with other operational functions to ensure success of project goals, operational readiness and compliance.
• Oversee the execution of maintenance, calibration, and planning business processes in line with existing policies and procedures. Drive corporate objectives for maintenance excellence in support of global ElevateBio APEx (asset performance excellence) program.
• Track facilities’ key performance indicators and drive continuous improvement and lean maintenance planning and scheduling practices.
• Develop, implement and drive a comprehensive engineering, maintenance and facility strategy for the site, and the supporting policies and procedures.
• Recruit top talent with every hiring opportunity and motivate and develop members of the department to be key leaders within the organization.
• Maximize the success rate for manufacturing operations by instituting programs to minimize mechanical failure and enhance equipment performance. Establish and oversee site reliability maintenance program.
• Lead site Business Continuity Response Team.

Requirements:

• Bachelor’s degree in engineering or other related science.
• 12+ years’ experience working in GxP pharmaceutical and/or biotechnology regulated environment.
• Experience in design, build, startup, and operations of GMP manufacturing facilities is highly desired.
• Experience in hiring, building, training, and leading high performance teams.
• Experience in representing as SME and defending GxP systems in audit setting
• Highly functional in a fast-paced dynamic company with the ability to prioritize issues under differing pressures and to work collaboratively with cross-functional teams.
• Excellent negotiation, organizational, interpersonal, and problem-solving skills
• Excellent written and verbal communication skills
• Substantial operational engineering experience
• Expert knowledge of Quality Assurance (QA) and Environmental, Health & Safety (EHS) standards
• Experienced working on all aspects of capital projects, including budgeting, design, construction, validation, start-up and ongoing operations.
• Experience in Central Utilities including, but not limited to: WFI, and purified water, compressed air, N2, chilled water, steam, heating hot water, electricity and sewage
• Proven leadership skills
• Exceptional project management skills