Summary: Lead the implementation of capital projects to support the sites strategic goals and capital investment plan. Responsible for the design, specification, contracting, procurement, construction, commissioning, and start-up of Facilities (Approx $2.5MM/yr budget) Capital Improvements Projects. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices and guidelines specified in the Stage gate project management process required by the job function. Responsibilities: Develops and implement engineering Capital Projects (Approx. $2.5MMyr). Assures that all design and project work is done in compliance with cGMPs, Company Global design and construction guidelines and procedures, and Local/Federal regulatory requirements. Assures projects are implemented following the Stage Gate process and assures compliance with Good Engineering practices, Regulations and Codes. Manages, maintains and tracks capital project budget to ensure it remains within budget and cash flow projection forecast. Manages outside contractors assuring construction and contractor safety and environmental compliance with all Company policies and Government regulations. Assures Quality in the construction and installation of all manufacturing equipment, facilities and utilities. Supports and implements changes to comply with GMP regulations and Company quality directives and procedures. Reviews quotations, develops specifications and generates purchase orders for construction and equipment procurement. Participates in define, plan, monitor, and implement the start-up of facilities and equipment to support operation schedule. Provides technical guidance and consulting to complex operation problems by providing engineering solutions and its implementation. Coordinates all activities associated to capital projects realization in the areas of Environmental, Safety, and Waste handling. Provides up-to-date communication regarding Project Engineering activities. Promotes a productive and effective business environment with internal and external customers. Identifies and promotes the best available technology to support the sites needs. Provides and keeps up-to-date Technical Engineering documentation. Manages installation and operational qualification of equipment and systems for client initiatives. Supports the Performance qualification efforts of Equipment and Systems installed by capital projects. Supports clients initiatives by providing guidance in the proper Project Management processes and procedures. Knowledge/Skill: BS in Engineering Five (5) years of experience managing capital projects. Three (3) years in a Drug Products Pharmaceutical or Medical Devices Industry License to practice Engineering in Puerto Rico, E.I.T. minimum. Working knowledge of Pharmaceutical Industry Regulations (cGMP, OSHA, EPA/EQB). Good interpersonal skills and be teamwork oriented. Knowledge of the state-to-the-art technology. Fully bilingual written and verbal (English/Spanish). Computer skills (Spreadsheets, AutoCAD, Word Processing, Microsoft Project, etc.). Technical skills such as Project Management (planning, scheduling, budgeting, controlling and reporting), Self starter and organized Ability to keep work pace and meet deadlines Good organizing and planning skills Willing to work irregular hours, weekends and holidays Assure self development of technical, administrative and interpersonal skills.
Ciudad: manati
