The Project Engineer will be responsible for directing and coordinating overall project work. This position will report into the designated Project Manager and will be a key contributor in the delivery of project goals in a timely manner. The Project Engineer will be required to work in a multidisciplinary team and take direction from the Project Manager and Subject Matter Experts (SMEs) towards planning and executing project tasks and activities.
- Coordinate & execute pre-construction walk downs with vendors and client teams for verification of field conditions.
- Redline P&ID's and electrical drawings based on the pre-construction walk downs.
- Submit findings of field walk downs to reviewers to determine system constraints and dependencies.
- Document impact of planned project work on existing systems and equipment.
- Assist in the design phase of the project by acting as liaison between vendor engineers and resolve any design queries.
- Assist in the creation and management of a project database to track project deliverables, schedule and punch list items.
- Participate in weekly project team meetings and provide weekly summary of tasks performed.
- Draft and execute risk work plans (RWPs) based on Oceanside, SHE requirements for construction and hot work.
- Enter work notifications in SAP. Provide details such as work impacts assessments, downtime requirements and LOTO requirements to planners.
- Assist in scheduling of work orders by identifying windows in production schedules.
- Assist in Factory Acceptance Tests at vendor sites if necessary.
- Work with vendors, GNE receiving and GNE REM teams to schedule deliveries & temporary or long term storage of project materials.
- Perform 5S on any storage spaces being used by the project and track project inventory.
- Observe field work and provide updates to project team on construction progress.
- Create and manage project punch lists and work with electrical/ mechanical subcontractors to resolve open issues.
- Review TOP's submitted by electrical/ mechanical/ equipment contractors and vendors.
- Create/ Document/ Mount asset tags for all equipment installations.
- Participate in project team meetings, issue meeting agendas and minutes; maintain action item, change and lessons learned logs.
- Effectively communicates with and influences all levels of the organization. Exercises good judgment in determining appropriate project communications to internal and external stakeholders.
- Ensure proper project documentation deliverables are identified and completed per project scope.
- Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area. Fosters a positive safety culture in which no one gets hurt.
- Perform work in compliance with current Good Manufacturing Practice (cGMP) requirements and corporate standards.
- Ensures assigned training requirements are current.
Skills: Knowledge, Skills and Abilities
- Exceptional interpersonal, communication, collaboration, and management skills.
- General knowledge requirements include all applicable building codes and related regulations, basic design and construction methodologies, (particularly in the process and mechanical discipline) and expertise in project management practices (including finance, risk management and control systems), EH&S regulations, Quality Assurance and IT systems.
- Special knowledge requirements include biopharmaceutical and pharmaceutical processes and facility design approaches, plus a solid understanding of cGMP requirements.
- Good understanding of clean room or classified area design/requirements.
- Familiarity with biopharmaceutical manufacturing, process equipment and supporting utility systems, especially those related to sanitary and sterile operations.
- Familiarity with biopharmaceutical process operation and process control.
- Knowledge of process, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation.
- Demonstrate strong spreadsheet, word processing and database skills necessary to process and present technical data in a clear and concise manner.
- Ability to review engineering drawings and specifications.
- Excellent organization and time utilization skills.
- Use creativity and innovation to address urgent and/or complex problems and propose solutions.
- Fluent written and verbal English (proficiency in additional languages is a plus)
Education: Education and Experience
- B.S. in Engineering (Chemical, Mechanical, Electrical preferred), Science or equivalent is required.
- Minimum of 2 years' experience successfully managing projects in the biotech/pharmaceutical industry.
- Experience from a background of manufacturing, design or construction.
- Strong working knowledge of Microsoft based programs
Work Environment/Physical Demands/Safety Considerations Work in standard office environment.
- May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make up or jewelry can be worn when working in the clean room environment.
- May work with hazardous materials and chemicals
Skills and Experience:
- BUILDING CODES
- CLEAN ROOM
- CONTROL SYSTEMS
- HAZARDOUS MATERIALS
- MANAGING PROJECTS
- PHARMACEUTICAL PROCESSES
- PROCESS CONTROL
- PROJECT ENGINEER
- PROJECT MANAGEMENT
- QUALITY ASSURANCE
- RISK MANAGEMENT
- ENVIRONMENTAL HEALTH
- EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
- FIELD WORK
- INTEGRATION INTEGRATOR
- INVENTORY LIAISON
- MICROSOFT WORD
- PRE-CONSTRUCTION PROJECT DOCUMENTATION
- PROJECT MANAGER
- REDLINE TRADING