50 Northern Avenue, Boston, MA 02210 Boston, MA 02210 US
- The Automation Engineer is responsible to provide GXP Engineering and Automation support function for Vertex’s Global Engineering Department. The qualified candidate will report to the Automation Engineering Manager, or designee. This role will be responsible for administration of Environmental Monitoring system, OSIsoft PI Data Historian, Automation Versioning application platform. The administration activities include data logger integration, integrating standalone automation systems to OSIsoft PI system as well as responsible for version control for PLC programming and critical VFD parameter management. Candidate must understand P&IDs, wiring diagrams and I/O configuration, system networking and field devices including VFDs, as well as Ethernet networking and security. The role will provide technical support, including design review, specification review, project management, change control and commissioning for manufacturing equipment in the drug product facility and GxP functional areas in a manner compliant with regulatory expectations, company policy and current procedures.
- Deliver automation and controls support for daily operations and troubleshooting PD and GMP Manufacturing equipment and other facility related stand-alone equipment.
- Install, configure, and modify data logger integration into our Environmental Monitoring System as well as troubleshoot any events impacting the system.
- Integrate standalone equipment to OSIsoft PI system via various interfaces such as OPC, RESTful, OdBC, BacNet etc.
- Manage version control for PLC programming and critical VFD parameter management as well as the qualified Facility Alarm response system including BMS and EMS. Candidates must understand P&IDs, wiring diagrams and I/O configuration, system networking and field devices including VFDs, as well as Ethernet networking and security.
- Manage creation and revision of Protocols, Reports, and Engineering Documents including, but not limited to drawings, user requirement specifications and SOP’s.
- Effectively work with cross departmental stakeholders to achieve departmental goals and objectives.
- Supply GEP (Good Engineering Practice) expertise drawn from own experience and/or supplemented by external resources to trouble shoot facility, equipment, or system issues.
- Develop and execute validation protocols as well as write technical reports and/or presentations relevant to processing activities and present to various levels of management and regulatory authorities.
- Lead Automaton Projects including the definition of the scope of work and specification development. Hands-on ability to develop robust systems and workflows that employ high re-use and require low maintenance.
- Review and/or draft Equipment Drawings, Electrical Diagrams, System Manuals, Engineering Protocols and Reports, and other Quality System Documentation.
- Support Deviation Management, C.A.P.A., and Change Control activities, as required. Serve as Automation S.M.E. to Quality, Manufacturing, and other Functions.
- Execute assigned duties on time and within budget; pro-actively telegraph delays and other issues to relevant stakeholders.
- Comply with all regulatory, corporate, and Quality System policies and complete other projects and/or assignments as required.
- B.A, B.S. in Engineering or related discipline with at least 5 years of relevant experience or M.S. with at least 2 Years of relevant experience
- Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.
- Experience with Data Integration: RESTapi, OSIsoft PI, SQL, OPC and database architecture.
- Experience working with Rockwell/Allen Bradley and Siemens PLC and HMI products.
- Knowledge of facility related engineering disciplines (MEP) in GMP manufacturing environment
- Excellent verbal and written communication skills applied on a global or multi-national basis.
- Strong interpersonal skills, including the demonstrated ability to manage through influence.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.