Project Engineer II - Pharmaceutical Engineering

Upsher-Smith•Maple Grove, MN

10d•Hybrid

About The Position

The Project Engineer II will plan and lead equipment selection and activities of technical engineering projects in a pharmaceutical manufacturing/packaging and development environments to ensure that goals and objectives are accomplished within prescribed time and funding parameters. Interviews and selects contractors and equipment suppliers based on project requirements. Establishes and maintains schedules and budgets for each phase of the project. Supports production, and other processes in a team-based environment. Performs activities in a variety of cross functional areas including production, manufacturing, equipment, facilities and process engineering. Conducts studies pertaining to cost control and cost reduction. On the basis of these studies, develops and implements plans and programs for equipment, facility and utility system modifications as well as revisions to operating methods. Plans production facilities and equipment layouts; determines the most efficient sequence of operations and workflow; and establishes methods for maximum utilization of production facilities and personnel. Participates as a technical subject matter expertise during internal and external meetings. This is a hybrid role - candidates must be local. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Essential Duties Leads project funding requests planning and execution of new capital investments and continuous improvement projects. Utilizes project tools to plan and lead technical engineering projects. Establishes and maintains project documentation, scope, schedule and budget. Generates User Requirements Specifications, and Functional Specifications, including generating and executing Factory Acceptance Tests protocols commissioning protocols and Site Acceptance Test protocols. Identify and select equipment vendors or contractors based on project requirements and knowledge of internal equipment and systems. Determine capability of equipment to establish feasibility and use of equipment on the production floor. Generate, review and maintain project, construction and technical documentation, including P&IDs, Process Flow Diagrams and Specifications. Evaluate, design and arrange production equipment within production facilities to ensure the most efficient and productive plant layout. Evaluate methods, machinery and manpower to determine, monitor and maintain efficiencies. Support, collaborate and participate in investigations and closures of Deviations and CAPAs. Provide guidance to the manufacturing groups regarding the best utilization of equipment and manufacturing techniques. Partners with or leads necessary cross functional team projects or troubleshooting activities to support manufacturing/packaging operations and other corporate projects as needed (Maintenance, IT, Manufacturing Operations, Tech Services, Facilities and Quality. Develops standards, to ensure optimum efficiency and generate methods to measure operating efficiencies. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Requirements

Bachelor's degree in Mechanical Engineering, Chemical Engineering or related engineering discipline.
Minimum of 6 years' engineering experience in a manufacturing environment required.
GMP experience strongly desired.
Experienced in Solid Oral Dose pharmaceutical manufacturing / packaging equipment, processes and facility operations strongly desired.
Project planning and project leadership experience required.
Building construction experience strongly desired.
Demonstrated ability to lead projects and/or participate on project teams; ability to collaborate and work productively with others in a team environment; professionally represents self and Company when working with vendors, suppliers and customers.
Ability to resolve complex problems and optimize machine performance; ability to manage project requirements and meet project deadlines; strong ability to analyze and interpret data and demonstrate exceptional problem-solving skills; ability to work independently with minimal supervision; understands and demonstrates the ability to follow Standard Operating Procedures (SOPs).
Computer Aided Design (CAD) knowledge desirable.

Nice To Haves

Professional Engineering license or EIT certification preferred.

Responsibilities

Leads project funding requests planning and execution of new capital investments and continuous improvement projects.
Utilizes project tools to plan and lead technical engineering projects.
Establishes and maintains project documentation, scope, schedule and budget.
Generates User Requirements Specifications, and Functional Specifications, including generating and executing Factory Acceptance Tests protocols commissioning protocols and Site Acceptance Test protocols.
Identify and select equipment vendors or contractors based on project requirements and knowledge of internal equipment and systems.
Determine capability of equipment to establish feasibility and use of equipment on the production floor.
Generate, review and maintain project, construction and technical documentation, including P&IDs, Process Flow Diagrams and Specifications.
Evaluate, design and arrange production equipment within production facilities to ensure the most efficient and productive plant layout.
Evaluate methods, machinery and manpower to determine, monitor and maintain efficiencies.
Support, collaborate and participate in investigations and closures of Deviations and CAPAs.
Provide guidance to the manufacturing groups regarding the best utilization of equipment and manufacturing techniques.
Partners with or leads necessary cross functional team projects or troubleshooting activities to support manufacturing/packaging operations and other corporate projects as needed (Maintenance, IT, Manufacturing Operations, Tech Services, Facilities and Quality.
Develops standards, to ensure optimum efficiency and generate methods to measure operating efficiencies.