Lead Facilities Engineer

Supervisory Responsibilities

• Manage the Facilities Engineers responsible for the execution of engineering projects and support of the operation of the facilities, utilities, and automation/controls
• Support the department head in recruiting, hiring, training, mentoring, coaching, and team building
• Lead cross functional internal and external teams during the execution of facilities projects and development of internal programs/processes

Duties and Responsibilities

• Develops engineering programs for facilities, utilities, and automation/controls needed to support projects assigned as facility improvements and repairs
• Manages engineering programs for facilities, utilities, and automation/controls in conformance with all applicable guidelines, policies, procedures, and regulatory requirements
• Supports facility operations with a systematic approach to troubleshooting, engaging industry experts, and successful execution to deliver solutions in an effective and timely manner
• Guides the programmatic design of facilities based on the intended use
• Provides input in the development of strategy, procedures, and policy development within the organization
• Demonstrates capability of developing and recommending strategies for change while effectively communicating the rationale for the changes
• Ability to negotiate and influence internal and external customers
• Proactively identifies, communicates, and monitors regulatory changes that could have an impact on quality or compliance within the organization
• Manages department and/or project budget
• Performs other related duties as assigned

Required Knowledge, Skills and Competencies

• Knowledge of cGMPs and Global Regulatory (e.g., FDA / MHRA / EMEA) guidelines and regulations acquired through education, experience, and training
• Thorough experience with facility systems regarding design, construction, and repairs; systems include, but not limited to, HVAC, compressed gases, water systems (i.e. purified water, steam), electrical, and automation/controls plus monitoring
• Experience in facility design regarding process flow, controlled zones, fit and finish, and structural components with respect to pharmaceutical facilities
• Experience interacting with regulators and clients during audits
• Effective written, oral, and interpersonal communication skills
• Excellent leadership skills with ability to motivate and coach employees
• Strong time-management skills and the ability to organize and coordinate multiple projects at once
• Proficiency in enterprise systems, Microsoft Office Suite and other office productivity tools, with aptitude to learn new software and systems

Education and Experience

• Bachelor’s degree in an engineering discipline or another discipline with equivalent experience and training
• Minimum of 10 years of overall experience in the pharmaceutical / biopharmaceutical industry preferred
• Minimum of 10 years of engineering experience with facilities and utilities preferred
• Minimum of 5 years of engineering experience with automation and controls required

Physical Requirements

• Physically able to work throughout Serán facilities and campus
• Prolonged periods of time standing, kneeling, crawling, or climbing ladders
• Required to work in settings with extreme cold or heat at various times of year
• Must be able to lift 15 pounds at times