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 Global Utility System Engineer IV provides guidance, direction and technical leadership for the design, selection, and maintenance of site utility systems, including but not limited to boilers, chillers, HVAC, compressed air, clean steam generation, RO and WFI systems to support operations across the AGC network. This role can be located in Denmark or the U.S.
- Create system standardization road map for the AGC network working with individual sites and Global Engineering.
- Guide site and global engineers responsible for supervising the design, startup, and maintenance of the utility systems at AGC facilities
- Develop and implement global 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 process development 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
- Work with individual site to develop site master planning strategy to encompass utility capacity analysis, system obsolescence remediation, and standardization.
- Work with site engineering to adopt global standards
- Other duties as assigned
KNOWLEDGE, SKILLS & ABILITIES:
- 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 moderately complex in nature where judgment is required in resolving problems and making routine recommendations to management
- Knowledgeable of operation, design, installation, and startup of key site utility systems.
- General Electrical, Mechanical, Control System knowledge.
- In-depth knowledge of documentation requirements for cGMP manufacturing.
- Demonstrated good interpersonal skills, customer focus, and professionalism.
- Ability to read, interpret, and troubleshoot engineering drawings, P&IDs, and electrical schematics.
- Knowledge of Biologics related production equipment.
- Quality – GMP experience within a pharmaceutical / or food manufacturing environment
- Lean, continuous improvement and cost reduction methods and implementation.
- Management and development of budgets,
- Demonstrated ability to develop and maintain clear and accurate documentation of process equipment or manufacturing processes.
- BS/MS in Engineering (Chemical, Biotechnology, Mechanical, or Electrical)
- Minimum of 8 years’ relevant industry experience required for BS candidates or 6 years’ experience for MS candidates
- Minimum of 5 years troubleshooting process automated systems in Biotech/Pharma process
- Lean / Six Sigma certification desirable
- Upstream and Downstream unit operations (centrifugation, filtration, precipitation, chromatography, bioreactors, CIP/SIP, mass flow technology, etc.) desirable.
- Experience with single use manufacturing technology operations and troubleshooting desirable.
- Experience managing a project team and delivering automation CAPEX projects.
- Experience writing reports for senior colleagues outlining new concepts, testing outcomes, and ongoing efficiency.
- Equivalent education and experience may substitute for stated requirements.
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.