Site Process Engineer

Role : Site Process Engineer

Location : Plainfield, IN, USA (Onsite)

Job Type : Full Time

Job Description

Must Have Technical / Functional Skills :

• Process Development : Play a key role in the development and optimization of process / product flows, value stream mapping, and introduction of automated systems (AGVs, Conveyors, etc.).
• Documentation : Create standard operating procedures, maintenance strategies, PFMEA documents, change controls, and other documents critical to project delivery.
• Regulatory Compliance : Ensure that automation systems meet corporate standards, including, but not limited to drawing management, version management, commissioning, qualification, validation, change management, and system maintenance.
• Project Management : Manage all aspects of project delivery, including identifying user requirements, executing commissioning & qualification activities, and scheduling to meet business and customer expectations.
• Safety : Model safe behaviors within daily work. Provide support to the operational areas to address any safety concerns. Execute projects and activities according to HSE requirements. Draft and develop HSE work plans.
• Data Integrity : Responsible for ensuring data integrity and good documentation practices while performing job tasks.
• Excellent Skills : Strong analytical, organizational, team, and project management skills.
• Documentation Skills : Experience in writing requirement specifications, design documents, installation protocols, test summary reports, etc.
• Software Development Lifecycle : Strong understanding of software development lifecycle and maintenance plans.
• Pharmaceutical Warehouse Business Process : Understanding of Pharmaceutical Warehouse Business Process.
• In-Person Work : Required to work in person in a site along with the team of process engineers.
• Knowledge : Knowledge of cGMP, SAP, Trackwise (QMS).
• Experience : Experience with Change Management, Deviation Management, Periodic Reviews, Commissioning & Qualification, Routine Data Monitoring / Reporting.
• Engineering Principles : Ability to apply fundamental engineering principles to process understanding, problem solving, and process improvement.
• Lean Manufacturing : Experience with the principles of lean manufacturing to drive continuous improvement and operational excellence.
• Team Environment : Ability to function in a team environment.
• Prioritization : Effectively manage and prioritize competing priorities.
• Communication Skills : Strong verbal and written communications skills. Must effectively communicate with Management, Operations, Maintenance, Quality, IT, and HSE. Must provide regular updates, conduct meetings, and produce presentations.
• Self-Management : Strong self-management and organizational skills.

Seniority Level

Mid-Senior level

Employment Type

Full-time

Job Function

IT Services and IT Consulting

Benefits

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