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Senior Director – Facilities & Engineering

Senior Director – Facilities & Engineering

CompanyElevateBio
LocationWaltham, MA, USA
Salary$Not Provided – $Not Provided
TypeFull-Time
DegreesBachelor’s
Experience LevelSenior, Expert or higher

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

Responsibilities

  • Be a member of the BaseCamp Waltham Site Leadership Team (WLT) representing Facilities & Engineering.
  • Be a champion of ElevateBio’s strong commitment to employee health and safety and environmental sustainability.
  • 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.
  • Review and approve plans and submittals related to HVAC, electrical, plumbing, clean utilities, clean rooms, etc.
  • 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.
  • 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.
  • Lead site Business Continuity Response Team.

Preferred Qualifications

    No preferred qualifications provided.