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 relates to facility/process/manufacturing engineering in the biotech and CDMO space.
• Demonstrated expertise in mentoring/team development, change management, planning/organizing.
• Demonstrated deep technical knowledge of facility/process/manufacturing Engineering in a biotech/pharmaceutical environment (stainless steel mammalian and cell and gene therapy).
• Ability to work on multiple projects and manage various priorities and timelines and adapt quickly to changing circumstances.
• High degree of customer focus (internal/external) and demonstrated collaboration in a team environment.
• Results-oriented with the ability to demonstrate resiliency, ownership, and drive toward execution.
• Staff Leadership: Translate mission, vision, and values into actionable goals and objectives. Provides adequate structure, direction, and feedback. Create an environment where staff feel valued, respected, and empowered. Show appreciation for and reward individual and group excellence. Demonstrates high standards of ethics and fairness. Takes appropriate risks and encourages staff to do the same. Works through conflict and ensures productive resolution. Maintains confidentiality of private and sensitive information. Focus on developing a diverse workforce through an authentic approach to Diversity, Equity, and Inclusion (DEI).
• Job Knowledge and Skills: Possess the required knowledge and skills to successfully perform the job. Rapidly embrace and apply new ideas and approaches where doing so adds value.
• Results Orientation: Know how to get things done in an effective and efficient manner with available resources. Plan and prioritize work, set and accomplish goals, and complete quality work on schedule. Maintain a sense of urgency in accomplishing work. Strive to improve company and individual performance. Take personal responsibility, lead by example, and be conscientious. Demonstrate initiative and committed to and enthusiastic about achieving company success.
• Decision Making: Make timely and sound decisions based on a combination of analysis, experience, and judgment. Consult others, as appropriate. Understands and takes into consideration how decisions impact others.
• Customer Focus/Teamwork: Develop and maintain adequate customer satisfaction levels with internal and external audiences. Demonstrate a bias toward service, quality, and teamwork. Build constructive and effective working relationships. Is committed to the success of all stakeholders.
• Communication: Cultivate a culture of openness and information sharing. Demonstrates integrity and honesty in all communication. Be a model of “speaking the truth” and advocate positions even when unpopular. Provide constructive feedback. Assume ownership and accountability.

EDUCATION/EXPERIENCE:
Required:

• Bachelor’s degree in a technical discipline (Chemical, Mechanical, or Electrical Engineering required) with a minimum of 12 years of relevant experience.
• 3 years of experience implementing or managing an effective technical group (Engineering, Maintenance, Reliability, or Facilities & Process Engineering) discipline at a biotech/pharmaceutical company.
• Knowledge of reliability engineering, preventive, condition-based, and predictive maintenance programs via Vibration, Ultrasonic, infrared, and oil testing regimes.
• Demonstrated knowledge of maintenance management systems – SAP, Maximo, or other CMMS systems.
• Demonstrated experience in the development and management of budgets.
• Demonstrated ability to develop and maintain clear and accurate documentation of process equipment or manufacturing processes.
• Experience managing Capital projects and project portfolios.
• Equivalent education and experience may substitute for stated requirements.

Preferred:

• Master’s degree in Engineering (Chemical, Mechanical, or Electrical Engineering) with a minimum of 10 years of relevant experience.
• Six Sigma and/or PMP certification preferred.
   

COMPENSATION RANGE:
$194,000 - $266,750 annually, based on experience

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Salary : $194,000 - $266,750