Leads and supports capital project planning and execution
Facilitates the application of automation engineering principles in the design, specification, construction, startup, and validation of GMP process and utilities equipment and systems for capital projects of scope and complexity
Leads and supports technical root cause analysis, incident investigations, and trouble shooting on process control issues related to electrical, instrumentation and control systems
Leads and supports new product introductions or new technology introductions by performing engineering assessments, implementing automation system configuration changes and supporting engineering runs
Devises new solutions to problems through adaptations and modifications of standard automation technical principles
Works closely with multiple subject areas, including manufacturing, process engineering, utility operations, maintenance, quality assurance, and validation to manage a diverse portfolio of projects
Provides technical support to commercial and clinical manufacturing as needed
Develops and implements critical initiatives for long-range planning and lifecycle upgrades of various Automation platforms with activities including managing a 5-year roadmap of systems, presenting high-level scope and cost estimates to executives for annual capital funding plan, and project management of initiatives once approved
Provides mentorship to the Automation Engineering team in daily operations
Communicates with multiple levels within the organization, highlighting issues and proposing solutions
Provides technical support and issue resolution 24×7 on-call support of Automation systems on a rotational-based frequency
Applies experience and knowledge of industry-standard processes and tools to attain an innovative organization
Requirements & Skills:
Bachelor’s Degree or Master’s Degree in Chemical or Electrical Engineering or related technical field
5+ years’ experience in Process Automation Engineering in a manufacturing support environment with at least 3+ years experience in the Pharmaceutical or Biotechnology industries
5+ years’ combined experience with the following product platforms: Emerson DeltaV DCS systems
Programming expertise with SCADA, PLC, HMI, and web-based applications
Familiarity with industry standards for batch control systems, SDLC methodologies, S88, 21 CFR Part 11, Validation, and GAMP
Strong control system automation background. Design, installation, programming, and validation of automated processes
Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services and non-GMP Utilities preferred
Experience with Tech Transfer, Process Design, and Commissioning
Experience with validation and change control methodology
