Site Process Engineer

Tata Consultancy Services; Plainfield (IN); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

An established industry player is seeking a Site Process Engineer to drive process development and optimization in a dynamic environment. This role involves managing project delivery, ensuring compliance with regulatory standards, and fostering a culture of safety. The ideal candidate will have a strong background in engineering principles, project management, and documentation practices. Join a collaborative team focused on continuous improvement and operational excellence, where your contributions will enhance the efficiency of pharmaceutical warehouse processes. This is a fantastic opportunity to make a significant impact in a vital industry.

Qualifications

• Strong understanding of process development and project management.
• Experience in regulatory compliance and documentation practices.

Responsibilities

• Develop and optimize process flows and automate systems.
• Manage project delivery and ensure safety compliance.

Skills

Process Development

Project Management

Regulatory Compliance

Safety Management

Data Integrity

Analytical Skills

Documentation Skills

Software Development Lifecycle

Lean Manufacturing

Communication Skills

Education

Bachelor's degree in Engineering or related field

Tools

SAP

Trackwise (QMS)

Job description

Role: Site Process Engineer

Location: Plainfield, IN, USA (Onsite)

Job Type: Full Time

Job Description

Must Have Technical/Functional Skills:

1. 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.).
2. Documentation: Create standard operating procedures, maintenance strategies, PFMEA documents, change controls, and other documents critical to project delivery.
3. 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.
4. Project Management: Manage all aspects of project delivery, including identifying user requirements, executing commissioning & qualification activities, and scheduling to meet business and customer expectations.
5. 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.
6. Data Integrity: Responsible for ensuring data integrity and good documentation practices while performing job tasks.
7. Excellent Skills: Strong analytical, organizational, team, and project management skills.
8. Documentation Skills: Experience in writing requirement specifications, design documents, installation protocols, test summary reports, etc.
9. Software Development Lifecycle: Strong understanding of software development lifecycle and maintenance plans.
10. Pharmaceutical Warehouse Business Process: Understanding of Pharmaceutical Warehouse Business Process.
11. In-Person Work: Required to work in person in a site along with the team of process engineers.
12. Knowledge: Knowledge of cGMP, SAP, Trackwise (QMS).
13. Experience: Experience with Change Management, Deviation Management, Periodic Reviews, Commissioning & Qualification, Routine Data Monitoring / Reporting.
14. Engineering Principles: Ability to apply fundamental engineering principles to process understanding, problem solving, and process improvement.
15. Lean Manufacturing: Experience with the principles of lean manufacturing to drive continuous improvement and operational excellence.
16. Team Environment: Ability to function in a team environment.
17. Prioritization: Effectively manage and prioritize competing priorities.
18. 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.
19. 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

• Medical insurance
• Vision insurance
• 401(k)