Project Manager

2 days ago

Rocky Mount, North Carolina, United States INTELLECTT INC Full time
Job Title: Project Engineer

At INTELLECTT INC, we are seeking a highly skilled Project Engineer to join our team. As a Project Engineer, you will play a critical role in leading and supporting qualification and commissioning activities for water pretreatment systems, high-quality steam generation/distribution systems, and Water for Injection (WFI) systems.

Key Responsibilities:
  • Support and contribute to project activities within a cross-functional team, ensuring effective communication and alignment of goals.
  • Define project strategies in accordance with current standard operating procedures and regulatory requirements.
  • Perform verification activities, including start-up, commissioning, and qualification of water pretreatment, high-quality steam, and WFI systems.
  • Initiate and manage change control processes, develop and approve project documentation, and ensure alignment with regulatory and operational standards.
  • Actively participate in technical meetings with clients, design teams, and construction companies to discuss project progress and technical solutions.
  • Oversee project timelines, resource planning, and progress tracking, ensuring timely and effective execution.
  • Assist in the generation, revision, execution, and approval of qualification protocols and reports, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Develop new standard operating procedures (SOPs) associated with project scope, ensuring compliance with best practices and regulatory requirements.
  • Contribute to the interpretation of qualification results and assist in the design and planning of subsequent project phases.
  • Request, evaluate, and share technical data with the project team to support informed decision-making.
  • Ensure all tasks are performed in strict adherence to regulatory standards and best practices, focusing on safety, compliance, and quality.
  • Provide regular feedback to client leadership on potential issues and concerns related to documentation and task execution.
  • Adhere to and promote safe work practices throughout the project lifecycle.
Requirements:
  • Bachelor's degree in engineering, science, or a related field.
  • Minimum of 6 years of experience in qualification and commissioning activities within the pharmaceutical industry.
  • Extensive hands-on experience with the commissioning and qualification of water pretreatment, high-quality steam, and WFI systems.
  • Proficiency in interpreting engineering drawings and discussing technical solutions, particularly for WFI systems.
  • Experience in developing Life Cycle documents, including Project Validation Plans (PVP), User Requirement Specifications (URS), and Risk Assessments.
  • Knowledge of welding procedures, documentation, and evaluation of welding activities.
  • Ability to develop Standard Operating Procedures (SOPs) for the operation and maintenance of WFI systems.
  • Strong understanding of FDA regulations related to commissioning, validation, and lifecycle management of GMP equipment and systems.
  • Familiarity with WFI guidelines from the International Society of Pharmaceutical Engineering (ISPE).
  • Ability to manage resource planning, prioritize deliverables, and track project schedule milestones.
  • Excellent interpersonal, verbal communication, and technical writing skills.
  • Fluency in English (reading, speaking, and writing) is required.

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