AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.
The Director/Senior Director, Engineering for AGC Biologics’ Longmont, Colorado, site is directly responsible for the management and execution of all Engineering related activities carried out on-site (process, automation, capital projects, utilities, equipment, facility and production maintenance, etc.). This includes the management of internal company resources, (assets, financial and personnel), external professional Engineering and other firms as part of the execution of equipment, facility or utility modification / upgrade, or expansion projects.
- Manages all support activities and functions necessary to ensure successful completion of engineering project
- Ensures all work carried out and equipment installed is safe, effective and in compliance with the appropriate industry standards.
- Under minimal direction, manages and oversees Capital Projects involving the planning, design, reconfiguration or construction, and qualification of facilities, utilities and equipment.
- Oversees and directs process engineering transfer and optimization activities to ensure robust technical capability of manufacturing equipment.
- Ensures all company and site Engineering policies and procedures are adhered to.
- Ensures all work undertaken is reflected accurately in up-to-date Engineering, Project and Maintenance information files.
- Serves as principal liaison with the professional Engineering firm(s), where these have been engaged in design and / or construction elements of projects being undertaken.
- Manages site activities necessary for successful execution of project(s) and ensure these are completed as
necessary to tie in with the overall project execution.
- Manages and resolves technical issues or changes arising throughout engineering project life cycle(s) whilst
ensuring the overall project objectives of scope, cost and schedule are adhered to.
- Seeks and retains approval for Engineering and facility designs from site; Manufacturing (who approve designs from a manufacturing operations perspective); Quality (who approve designs from a regulatory compliance standpoint)
- Ensures all facilities, utilities and / or equipment are handed over effectively to site User Departments and Maintenance personnel.
- Proactively manages the site capital planning and execution processes.
- Builds long-term Engineering and Capital Project plans
- Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)
- Develops and implements equipment reliability improvement projects
- Completes technical review and evaluation of complex engineering processes
- Responsible for all site maintenance (production and facility) activities.
- Responsible for site services (pest control, housekeeping, security, etc.)
- Coaches and mentors engineering colleagues
- Performs other duties as assigned
KNOWLEDGE, SKILLS & ABILITIES:
- Extensive experience within personalized medicine, cell therapy or gene therapy is strongly preferred.
- Comprehensive technical knowledge of pharmaceutical equipment and plant design;
- Comprehensive equipment and plant control systems understanding (distributed control systems, local and high speed equipment control, building management systems);
- Experience with pharmaceutical industry standards and requirements (Minimum US GMP);
- Thorough knowledge of the utility, equipment and facility validation process
- Proven expertise in planning/organization/execution of complex capital projects in a GMP environment.
- Demonstrated expertise developing integrated CAPEX site master plans.
- Demonstrated experience in RCA process and helping teams solve complex issues.
- Experience leading and developing a diverse engineering team consisting of project, automation, and process engineering, and maintenance functions.
- Experience managing maintenance teams and developing robust maintenance processes.
- Demonstrates a disciplined approach to making decisions that are based on data and facts and is consistent with Vision/Business Goals and Values
- Bachelor’s degree in Engineering (MS preferred) and/or equivalent combination of education and experience
- Director - Minimum of 10 years senior level engineering management experience.
- Senior Director – Minimum of 15 years senior level engineering management experience.
- Equivalent education and experience may substitute for stated requirements
$171,250 - $242,500 annually
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