Senior Automation Engineer

Net2Source (N2S) · United States

Job Description

Work location: Indianapolis, New Jersey, and California (Onsite)

Duration: 12+ Months contract position.

Purpose

• Support design, implementation, validation and maintenance of automation systems in projects and site operations
• Support internal and external technical request on automation system and its associated network.
• If needed, create site SOPs, validation documentation and Engineering documentation.

Key Responsibilities

Automation

• Plan & implement the deployment of Coding / Recipes (DCS / Scada / PLC's / Control Networks)
• Design, implement & maintain Historian Configuration for modules / visualization / OPEX
• Implement and coordinate Software Change Controls associated with automation / system changes per SOP
• Own and develop automation solutions with change control doc that are consistent with specific needs of the manufacturing environment.
• Take an active role in driving the solutions or troubleshooting effectively on correct direction for all automation related projects. Leverage best practices and expertise across the Engineering network.
• Actively moving the task ( such as engineering change, test, documentation) by complying with quality requirement.
• Drive the Automation roll-out process at the Site level ensuring cost, schedule and technical solution are achieved

Operational Technology (OT)

• Manage operations for (OT) systems, tools and applications, ensuring their stability and integrity, while meeting customer service levels.
• Support OT systems business owner in all occurring technical topics and operate all IT/OT services, systems and applications, to monitor events that occur in the enterprise environment.
• Ensuring that configuration items (any component that needs to be managed to deliver an IT/OT service) are identified, accounted, reported, verified and audited.
• Implement / execute the end-to-end processes required for OT systems and Cyber security requirements.
• Ensure that an up-to‑date asset inventory for all technology assets is maintained.
• Take accountability to ensure adherence to security and compliance policies and procedures
• Perform validation support.
• Identify technical solutions.
• Prepare and update Equipment Specifications and System Requirements in project phase (e.g. User Requirement Specification, configuration specification).
• Prepare Functional Specifications and test approach in project phase.
• Prepare, review and approve protocol, deviation, drawings, lists, schedules, diagrams, layouts, calculations, and datasheets in project.
• Perform new equipment FAT / SAT / inspections in project.
• Execute work orders for projects as per method statement.
• Perform commissioning and troubleshooting activities.

(Re-) Qualification

• Create DQ, IQ and OQ protocols.
• Execute DQ, IQ and OQ.
• Provide technical trouble shooting during PQ and validation.
• Manage and maintain the punch list or task tracking list.

Regulations

Familiar and knowledgeable of the following regulatory requirements as applicable to computerized system validation (CSV) and data integrity (DI) requirements and industry standards and best practices.

• Standards and regulations
• FDA 21 CRF Part 11 “Electronic Records and Electronic Signatures”
• EU GMP Annex 11 “Computerized Systems”
• FDA General Principles of Software Validation
• WHO Guidelines on Validation – Appendix 5 Validation of Computerized Systems
• Data Integrity guidelines (MHRA, EMA, FDA, WHO, PICS)
• ISPE GAMP5
• PIC/S Good Practices for Computerized Systems in Regulated ""GXP"" Environments

What are the Mandatory skills and skill proficiencies required for this position?

• Strong expertise in automation systems design, implementation, validation, and maintenance including hands on experience with DCS/SCADA/PLC, OT management, and regulatory compliance.
• Excellent problem solving, project engineering, and documentation skills aligned with industry standards and GMP requirements.