Senior Director, Engineering

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

JOB SUMMARY:
AGC Biologics is seeking a Senior Director of Engineering to oversee the strategy and execution for all of Colorado facility/manufacturing Engineering functions. This position will provide strategic leadership for the Engineering function including, but not limited to, Capital Projects, Equipment & Facility Maintenance, Automation Systems, Reliability, Engineering Compliance, staff management, and leadership. In addition, this position will ensure that maintenance processes and standards are developed, implemented, and followed for all Engineering functions.

PRINCIPAL RESPONSIBILITIES:

• Provide leadership to a diverse group of talented engineers and technicians, developing methodologies to deliver on the infrastructure plans in a timely and cost-effective manner, while adhering to safety, sustainability, and quality imperative.
• Demonstrate leadership through coaching and developing staff, managing for high performance, attracting and retaining talent, and communicating effectively to influence impact.
• Manage the development, delivery, and execution of the Facilities Master Plan projects through the management of a large capital budget; execute capital plans in a disciplined manner ensuring Master Plan objectives including budget, schedule, quality, safety, and sustainability are met or exceeded.
• Strategically develop a thoughtful, forward-looking Master Plan, maximizing the use of current AGC Biologics assets while developing plans with optionality factored in for future growth.
• Oversee all project design, planning, and time and cost estimation with respect to the construction and maintenance of structures, facilities, systems, and components.
• Oversee the development and application of engineering standards and procedures, providing guidance on issues within the engineering function.
• Create and execute an Engineering roadmap that optimizes business processes (design, construction, project controls, maintenance, etc.) for simplicity, adds systems for efficiency, and standardizes work functions for consistency.
• Instill/ensure discipline in key areas such as Supplier/partner selection, Spare Parts Management, Maintenance Service Agreements, Knowledge management, and Capital planning.
• Establish and lead the team to world-class targets as they relate to Engineering maintenance metrics and Sustainability operations.
• Analyze current processes and approaches to Engineering maintenance practices and Sustainability and develop a vision for world-class performance within the biopharmaceutical sector.
• Establish policies and procedures for engineering-related matters, assuring management reporting through the development metrics and performance indicators to monitor and trend results and taking actions to correct, prevent, and/or improve execution and future performance.
• Ensure effective and compliant operations in accordance with site registrations, cGMPs environmental regulations, and state requirements; acquire and maintain permits and certifications as necessary.
• Effectively execute projects that improve quality and safety, reduce product cost and risk, and ensure efficient and effective plant production capabilities. This includes the development and preparation of the required cGMP documentation required for the engineering and facility projects as well as the ongoing facility, equipment, and utility maintenance programs.
• Provide oversight to assure completion of all phases of a project in a timely and efficient manner, meeting or exceeding budget expectations.
• Apply Lean and Six Sigma methodologies to drive process improvement.
• Participate as a senior member of the Site Leadership Team.

KNOWLEDGE, SKILLS & ABILITIES:

• Working, hands-on knowledge in the following systems: Compressed Air, Steam, Chilled Water, Pharmaceutical Utilities, Purification, Filling, Bioreactors, Automation, Sterilization, and Water Purification.
• Demonstrated ability to work in a dynamic environment and transform culture/organization into alignment with business strategy.
• Demonstrated experience utilizing Lean and Six Sigma methodologies.
• Excellent verbal and written communication skills.
• Strong interpersonal skills, including the demonstrated ability to manage through influence.
• Good business skills, including budget management experience.
• Demonstrated planning and organizational skills including project management.
• Proven knowledge of current practices