Sr. Facilities Project Manager
Title: Senior Facilities Project Engineer Location: Gaithersburg, MD Schedule: M-F 8-5 Type: Direct/Permanent Start date: Immediate Our client is seeking a Senior Project Engineer to work in our Gaithersburg, MD Engineering group. This position reports directly to the Sr. Manager of Capital Projects but works closely with all members of the Engineering and Tech Services Department, Validation, Facilities, and the Manufacturing Operations group. Responsibilities: The incumbent will be responsible for managing site based facility projects in a highly regulated cGMP environment, coordinate project scope definitions, manage project timelines and budgets, develop schedules and collaborate with stakeholders, etc. The incumbent will be responsible for working with vendors and consulting engineers to ensure project execution meets quality standards. Provides multi-disciplinary technical input to project design personnel to ensure compliance with site requirements/project specifications/codes and permitting requirements. Serves as the Facilities Core Team Leader for all site-based process transfers and product commercialization projects. Lead implementation of projects involving critical building systems including, but not limited to MEP, HVAC, ISO Classified Clean Rooms, WFI, Clean Steam, Clean Compressed Air and High Purity Gases, Cooling Tower Water, Chilled Water etc. Communicate cross-functionally with Project Stakeholders, customers, vendors, suppliers, contractors, and management on project related activities. Collaborate with and coordinate in-house Engineering and Maintenance staff, outside vendors, and internal operations teams to effectively transition projects through their lifecycle, including design, implementation, start-up/commissioning, validation, and turn-over to the customer. Define method and plans for project execution consistent with the business need and justification. Identify key project risk areas and potential resolution plan and related impact. Coordinate definition, preparation and delivery of project deliverables, design documents, and bid packages. Evaluates and approves engineering and project design changes, specifications, and drawing releases. Provide status and progress reports to management and project team. Coordinate plant training needs to ensure a smooth transition and project closing Conduct surveys and prepare schematic, preliminary and work drawings for the construction and maintenance of new or remodeled facilities. Consult with architects, engineers, owners, and contractors regarding preliminary layout, construction procedures, and code requirements that apply to building projects. Inspect existing facilities and utilities to determine their condition and prepares reports to document the condition, deficiencies observed, designs necessary for repairs, and estimated cost of repairs. Manages cost, schedule, and scope of facilities Capital projects including renovations, new equipment installs, and new construction. Oversees facility projects to ensure contractor compliance with safety, site cleanliness, and all current good manufacturing practices (cGMP s). Coordinates projects with other departments to minimize risk and impact to existing and ongoing operations. Provide leadership and direction to staff involved in the designs of site facilities, and schedules Ability to maintain documents, records, and prepare reports and correspondence related to the work. Manage and execute appropriate change control for the revision of existing equipment and systems maintenance SOPs. Interacts with contractors and vendors to receive and negotiate bids and monitor the progress and completion of projects. Requirements: Engineering Degree with a minimum of 10-15 years of experience in the design and construction of GMP and non-GMP production facilities in a manufacturing plant environment, preferably in the Medical device or Pharmaceutical industries Experience leading capital projects in cGMP environment with demonstrated understanding of managing spending and schedule. Experience with CMMS and QMS systems and reading/interpreting CAD drawings. Able to work with minimal supervision Must be available in emergency situations, and / or work flexible hours.