NJ Employer Process Engineer - PNJ2016-053 in Princeton, New Jersey

Job Description:Summary: Lead engineering projects to start-up and commissioning of new manufacturing facilities, equipment, and processes, as well as support and improve existing operations. Lead projects independently, or as the leader of a cross-functional team. The role will facilitate and support execution of projects from conception through design, including equipment specification, startup, commissioning, and validation as necessary. This position will lead, execute, and coordinate activities of the internal project team and any external resources, including outsourced contractors and consultants. Will collect and report data and KPIs to both internal and external stakeholders.Essential Functions:Manage process engineering projects from conception through startup.Evaluate, develop, and manage the design and development of process based engineering projects.Analyze and propose solutions to technical problems; considers alternative projects.Collaborates with Operations, Facilities, and Quality, EHS, and Financial organizations to develop project scopes, cost estimates, and schedules.Responsible to develop the project scope, budget and schedule into a Capital Appropriations Request (CAR, application for approval of funds) for capital projects.Coordinate internal/external resources to ensure project milestones are achieved.Maintain cost and schedule control on assigned projects from initial design through successful manufacturing of quality products.Ensures certification and functionality through commissioning, validation and qualification of projects and current laboratory operations.Advise Site Leadership on best courses of action on projects, technical matters, and project economics.Provide regular communication up and down organization on status of projects.Represents Company in contracts with outside vendors, contractors, engineers, regulatory authorities, and consultants on a frequent basis during execution of a major project.Maintains and/or creates necessary engineering documentation (FRS, URS, DDS, drawings, data, software, etc.) for responsible equipment.Responsible for the overall management and execution of assigned projects to meet the goals of scope, cost and schedule.Experience and Skills:Education:Bachelor of Science degree in Engineering required. Chemical, Bio, or Mechanical Engineering preferred. Electrical, Industrial or other Engineering field acceptable with relevant work experience.Experience:2+ years of Process Engineering/Project Management experience in the pharmaceutical manufacturing (or similar) industry.Solid knowledge of global current Good Manufacturing Practices (cGMP) in active pharmaceutical ingredients and/or finished pharmaceutical manufacturing.Validation experience in a pharmaceutical environment is preferred.Proficient with CAD and Microsoft Office applications. Microsoft Project is a plus.Must possess a high level of proficiency in a technical core competency.Active participation in industry organizations such as ISPE is a plus.Excellent verbal and written communications skills with the ability to build and drive cross-functional teams.Strong customer focus and drive for results with strong problem-solving abilities.Capable of setting clear priorities, organizing work, and making quality decisions in a fast-paced business setting.Equivalency:Equivalent combinations of education, training, and relevant work experience may be considered.Competencies:Experience in managing complex engineering projects through cross-functional teams.Knowledge and experience in a regulated environment to ensure regulatory compliance is achieved. GMP experience is preferred.Familiar with upstream and downstream bioprocess operations and equipment.Define process requirements and establish project design criteria based on engineering analysis and evaluation. Prepare detailed functional specifications.Experience in critical engineering tasks; forecasting, specif