JC Automation

About Company:

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

ABOUT THE ROLE

The Automation SME – Project Engineer is accountable for technical leadership and project coordination of assigned Automation/IT capital projects. Execution activities may be performed directly by the resource or through oversight and coordination of contractors and system integrators. As a candidate, your company must meet BMS policies, guidelines, and other requirements.

2.1. Capital Project Execution 

• Lead the development, planning, and execution of Automation/IT/Network Capital Projects.
• Act as the technical project lead for Automation/IT scope, coordinating engineering, quality, validation, IT, and vendors through all project phases. 
• Define project scope, schedules, cost estimates, risks, and deliverables.
• Provide routine project status reporting, milestone tracking, and risk mitigation plans.
• Resolve complex technical and design issues arising during project execution, construction, and start‑up, ensuring decisions support regulatory compliance, safety, product quality, cost, and schedule objectives.
• Provide clear and timely communication on Project Engineering activities, risks, and milestones to internal stakeholders and management.  Support Capital Appropriation Requests (CARs), budgeting, and financial tracking.
• Coordinate project execution activities with EHS to ensure compliance with safety, environmental, and waste‑handling requirements throughout all project phases.
• Review vendor quotations, develop technical specifications, and support procurement activities, including purchase requisitions and technical evaluation of equipment and services for Automation/IT capital projects.

2.2. Automation and Systems Engineering

• Lead and/or support the design, specification, procurement, installation, commissioning, and start-up of automation and computerized systems.
• Provide SME support for systems including, but not limited to:
• PLCs, HMI, SCADA, DCS/BAS o DeltaV, Rockwell Automation, FactoryTalk, Siemens, Wonderware o MES systems (e.g., Syncade), data historians (OSI PI), databases (MS SQL), and virtualization platforms
• Review and approve automation architectures, network designs, and system configurations.
• Identify and promote best available automation technologies to meet site and corporate needs. 2.3. Compliance, Quality, and Validation
• Ensure all project activities comply with: o cGMP, FDA, EMA, OSHA, EPA/EQB o 21 CFR Part 11, Engineering, IT, and Security standards
• Support execution of the Computer System Validation (CSV) lifecycle, including requirements, specifications, testing, and qualification.
• Support Performance Qualification (PQ) of equipment and systems installed under capital projects.
• Participate in quality events, including deviations, investigations, CAPAs, internal audits, and regulatory inspections related to automation systems.
• Ensure Automation and computerized systems are delivered in a validated state, in compliance with CSV requirements.
• Support preparation, review, and execution of validation documentation.

2.4. Contractor and Vendor Management 

• Manage and coordinate external contractors, system integrators, and vendors. 
• Ensure contractor compliance with safety, environmental, security, and quality requirements. 
• Review technical proposals, quotations, and specifications. 
• Coordinate FAT, SAT, commissioning, and start-up activities with vendors and internal stakeholders. 
• Ensure quality of construction, installation, and system implementation activities for Automation and related infrastructure in accordance with approved designs, specifications, and GMP requirements.

2.5. Documentation and Change Control 

• Develop, review, and maintain technical and project documentation, including:
• URS, FRS, DS, and configuration documents.
• SOPs (Operations, Maintenance, Security, Backup/Restore, Disaster Recovery).
• Execute and support change control activities related to automation and computerized systems.
• Ensure proper documentation control, traceability, and data integrity.

2.6. Cross‑Functional Collaboration 

• Serve as the Automation Project SME for Manufacturing Business Units. 
• Collaborate with Manufacturing, Quality, Engineering, Maintenance, IT, EHS, Purchasing, and Corporate teams. 
• Provide technical guidance to resolve complex operational and project-related issues. 
• Support client initiatives by ensuring adherence to Project Management processes and governance.

REQUIREMENTS & QUALIFICATIONS

Required

Preferred

SKILLS

Technical Skills

Soft Skills