0958 Automation Engineer IV
Duties:
Purpose:
The senior automation engineer provides technical leadership and accountability for automation engineering in the initiation and delivery of capital projects and engineering services for commercial and clinical manufacturing-related facilities.
Responsibilities:
Work effectively on a multi-discipline engineering capital project team, as well as other project-related cross-functional teams with representatives from departments throughout the Pharmaceutical Technology Operations organization.
The primary areas of focus for this position will be the execution of Automation projects from design through qualification and the leadership of cross-functional initiatives in automation technology.
Championing, initiation and leadership of cross-functional, strategies/initiatives required to maintain leadership in automation technology.
Planning and Execution of Projects including: project approach and resource needs, options analysis, automation and equipment design, engineering document development, and system ownership through the project delivery phases of plan, design, procure, construct, commission and qualification for cGMP and development facilities.
Technical Analysis including: automation and technology plant fits, capacity and equipment utilization, and assessment of applicable new technologies.
Areas of expertise include systems and equipment within biologics drug substance and GMP utilities.
This position requires coordination of the Company and/or contract engineering resources.
Facilitating meetings, directing engineering firms and consultants, field supervision, equipment inspection and start-up, construction trade coordination, and training of operational staff are often required.
Success in in these areas will depend upon the individual’s ability to effectively communicate, collaborate, and foster positive interactions with team members, while diligently managing adherence to project scope, budget and schedule.
The automation engineer is expected to be an effective communicator of ideas, project goals and results.
With minimal supervision, is expected to make presentations and updates to senior management and in broader forums both internal and external to the Company.
The automation engineer is expected to contribute to increasing the efficiency and effectiveness of the Automation Engineering department by contributing towards infrastructure improvements to guidelines, procedures, practices, standards and cross-functional business processes.
Skills:
Experience as automation lead for multiple complex capital projects within the pharmaceutical industry.
Must have experience with distributed control systems, hardware design, software development methodologies and automated system life cycle support in a regulated industry, specifically, with Emerson DeltaV and Syncade is highly desired.
Experience with APACS, Archestra, and InBatch is a plus.
Familiarity with Instrumentation, Systems, and Automation Society (ISA) Standards S88 and S95 as well as the International Society for Pharmaceutical Engineering Understanding of (ISPE) Good Automated Manufacturing Practice (GAMP) Guide to the Validation of Automated Systems.
Thorough understanding of cGMPs particularly as they relate to the operation, validation and maintenance of computer-controlled systems.
Significant capital project experience, with proven expert knowledge of cGMP compliance requirements. Able to represent automation engineering design, construction and qualification processes to regulatory authorities.
Champions self-initiated or assigned projects.
Justifies project goals to senior management within and outside the company.
Aggressively drives areas under their control.
Makes decisions based on corporate rather than functional area priorities.
Acts as a mentor for those with similar or less engineering expertise.
Develops highly innovative and ingenious solutions to unusually complex problems.
Contributions are integral to the achievement of major company objectives and the Company’s overall technological and organization capabilities.
Strong technical leadership, collaboration, and sound business value based prioritization and problem solving skills.
Education:
BS. in Chemical Engineering, Electrical Engineering or equivalent with 10 or more years pharmaceutical technology experience in industry or academia after receiving their Bachelor’s degree, at least 7 of which involved automation design, automation performance analysis, or automation engineering services.