Facilities Engineer, Principal

About AGC Biologics  

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.   

 SUMMARY:

The Facility Engineer, Principal provides guidance, direction and technical leadership for the design, selection, and maintenance of site utility systems, including but not limited to Clean Rooms, CTCs, HVAC, boilers, chillers, compressed air, clean steam generation, RO and WFI systems to support site operations. Must be a SME in key critical engineering disciplines (Clean and Dirty Utilities, WFI, HVAC, CTCs etc.) to support the startup, commissioning and lifecycle support of new and existing/legacy systems at the Boulder and Longmont Colorado manufacturing facilities.

PRINCIPAL RESPONSIBILITIES:

• System Owner of utility equipment for assigned functional areas.
• Liaison between QC, MSAT, capital projects, automation and maintenance support groups in support of GMP manufacturing.
• Responsible for HVAC design and classification of cleanrooms, ensure they are maintained and compliant for Manufacture of Sterile Medicinal Products
• Ensure all work is carried out and equipment is installed in a safe, effective and compliant manner compliant with industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, Corporate Quality and EHS directives.
• Responsible for supervising the design, startup, and maintenance of the utility systems at AGC facilities
• Mentor the development of a cross-functional engineering team (mechanical, electrical, automation).
• Manage resolution of major equipment breakdowns and quality issues in the suites by driving a robust root cause analysis (RCA) process.
• Computer literacy in a CMMS (Computerized Maintenance Management Software) such as Blue Mountain or similar computer based maintenance program desirable.
• Quality – GMP experience within a pharmaceutical / or food manufacturing environment.
• Develop and implement utility system strategy and engineering standards.
• Drive continuous improvement and long range planning for equipment recapitalization.
• Assist sites to deliver utility and expansion projects on schedule and budget.
• Work closely with key customers in operations, quality, and MSAT to ensure regulatory compliance and utility system service levels meet requirements.
• Communicate and collaborate with technical and management staff within Operations, Engineering, MSAT, and Quality.
• Promote and maintain a safe working environment for team and customers
• Develop site master planning strategy to encompass utility capacity analysis, system obsolescence remediation, and standardization.
• Work with site engineering to adopt global standards.
• Manage vendor contracts and relationships.
• Other duties as assigned

 KNOWLEDGE, SKILLS & ABILITIES:

• Adaptable; must be willing to remain flexible to accommodate changing business conditions, work requirements and scheduling needs in a rapidly changing environment.
• Strong written, verbal and interpersonal communications skills.
• Strong analytical and problem solving skills and experience applying these skills to resolve technical problems.
• Strong skills and experience in MS Office products (Word, Excel, Outlook, PowerPoint).
• Computer literacy in a CMMS (Computerized Maintenance Management Software) such as Blue Mountain or similar computer based maintenance program desirable.
• Demonstrated ability to work on assignments that are complex in nature where judgment is required in resolving problems and making recommendations to management.
• Knowledgeable of operation, design, installation, and startup of key site utility systems.
• General Electrical, Mechanical, Control System knowledge.
• In-depth know