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. 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 Manager, Global Automation provides managerial direction and technical leadership for the design and development of automation and control systems, including Building Management Systems, Data Acquisition, and Process Control Systems to support operations across the AGC network.
- Create the automation the road map for the AGC network working with individual sites and Global IT.
- Guide automation engineers responsible for supervising the design, startup, and maintenance of the automation systems at AGC facilities
- Develop and implement global automation strategy and engineering standards
- Drive continuous improvement and long range planning for equipment recapitalization
- Assist sites to deliver automation projects on schedule and budget
- Own all global automation systems
- Work closely with key customers in operations, quality, and process development to ensure regulatory compliance and automation 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 IT to develop automation networking standards
- Work with site automation leads 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 Electrical, Mechanical, Control/SCADA, PLCs, AC / DC drive systems, industrial control system protocols, (controlnet, devicenet, profibus , profinet, BacNet and Ethernet/IP), DCS (Delta-V), Process Improvement Methodologies, and Root Cause Analysis (RCA).
- 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.