What are the responsibilities and job description for the Project Engineer position at RGD Project Management, Inc.?
Company Description
RGD Project Management, Inc., based in Cary, NC, specializes in Project Management, Construction Management, and Technical Support Services for the biotech, pharmaceutical, high-tech, and industrial sectors. For over 23 years, RGD has maintained a reputation for delivering excellence by prioritizing safety, efficiency, quality, cost, and schedules. The company supports capital projects through all phases, from feasibility analysis to commissioning and validation. RGD values teamwork, individual growth, and family-oriented principles and offers comprehensive benefits to permanent employees, including medical insurance, life insurance, paid time off, and 401k plans.
Role Description
This is a full-time on-site role based in Cary, NC, for a Project Engineer. The role involves supporting the planning, design, execution, and completion of construction projects within the biotech, pharmaceutical, and industrial sectors. Daily responsibilities include coordinating with cross-functional teams, assisting in project feasibility analysis, managing engineering designs, monitoring construction activities for compliance, and ensuring safety, efficiency, and adherence to project schedules and budgets. Additionally, the role requires working collaboratively to maintain regulatory compliance and rigorous documentation standards.
Responsibilities:
• Review of Vendor Documentation (including but not limited to Sequence of Operations, Alarms, I/Os list, HMI Screens etc), provide comments and confirming updates accordingly.
• Daily/Weekly meetings with supporting Vendors and Client to ensure adherence to system requirements and site SOPs.
• Recurring internal meetings with CSV team to appropriately distribute tasks and receive feedback on additional information to be requested.
• Writing, reviewing, and executing computer validation documentation including but not limited to System Classification Assessments, User/Functional Requirement Specification, Functional (hardware/software) Specification, IQ/OQ/Protocol/Testing, Traceability Matrix, Validation Summary Report etc.
• Teams or in-person meetings with project Vendors and Client teams to perform Alarm and Risk assessments per client templates and acquiring approvals.
• Validation of computerized systems, in accordance with site procedures.
• Assessing electronic/paper records aiming to identify Data Integrity gaps with Risk-Based Approach in order to suggest the most appropriate mitigation/remediation actions.
• Ensuring that all project-related issues and deviations are recorded, communicated with Project Manager, approved and resolved accordingly.
• Ensuring that all team members are adequately trained and equipped to perform test executions.
• Identifying gaps in system design and/or sequence of operations promptly and coordinating with necessary teams to resolve it.
• Ensuring all assigned activities are being performed in accordance with approved change control.
• Provide support and/or draft/revise existing or new site SOPs as required.
• Provide support to Client teams on performing impact assessments as required.
• Perform knowledge transfer activities to Client Validation and Quality teams, explaining the Start to Finish system operation and as well as coordination of System Walkdown as requested.
• Performing impact assessments and ability to quickly resolve or provide resolutions to any validation or quality related roadblocks.
• Assisting with internal team management activities, understand and relay critical team and project related information.
• Translating mechanical operating principles of utility systems into functional requirements for control systems.
• Assessing the impact of control system changes on the mechanical performance and validated state of utility systems.
• Participation in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) for required systems and associated control panels to gain understanding.
• Assessing the impact of PLC hardware and software changes on the validated state of the system.
Qualifications
• At least 8 years of experience in the Pharmaceuticals field
• Comprehensive understanding of the individual phases and ability to draw system boundaries for Qualification Activities (IQ/OQ/PQ)
• Ability to understand and assess the future phase activities related to integration with existing site systems, integration to new systems, working in conjunction with different vendors to acquire appropriate information
• Water Systems (PurW, WFI, Steam): Understand the mechanical and purification processes for Purified Water (PW), Water for Injection (WFI), and Steam generation and distribution (e.g., RO, EDI, stills, piping, pumps, heat exchangers). Understand the critical control points and alarming related to these systems.
• Clean Compressed Air & Gases: Knowledge of compressors, dryers, filters, and distribution networks for clean compressed air and other process gases.
• Process Cooling/Heating Systems: Familiarity with mechanical aspects of chillers, heat exchangers, and associated piping for process temperature control.
• Studio 5000 Logix Designer: Ability to read, understand, and review ladder logic, structured text, function block diagrams, and sequential function charts within Rockwell PLCs (e.g., ControlLogix, CompactLogix).
• FactoryTalk View SE/ME: Understanding of HMI (Human Machine Interface) development, alarm configuration, data logging, and trending within FactoryTalk View.
• Historian (e.g., FactoryTalk Historian SE): Knowledge of data acquisition, storage, and retrieval for historical data.
• Network Configuration (EtherNet/IP): Understanding of Rockwell network architectures and communication protocols.
• PLC Processors: Familiarity with various Rockwell PLC processors (e.g., ControlLogix, CompactLogix) and their capabilities.
• I/O Modules: Understanding different types of input/output modules (digital, analog, specialty) and their wiring.
• Communication Modules: Knowledge of communication cards and network adapters.
• Drives (VFDs): Basic understanding of Rockwell Variable Frequency Drives (VFDs) and their integration with PLCs.
• Strong understanding of GxP (Good Practice) regulations and data integrity principles.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Detail-oriented with a focus on accuracy and quality.
• Ability to work independently and as part of a team.