Sr. Project Engineer

The Sr. Project Engineer plans, directs, and leads the activities of complex engineering projects in a pharmaceutical manufacturing/packaging and development environment to ensure that goals and objectives are accomplished within prescribed time and funding parameters.  Interviews and selects contractors based on project requirements. Establishes and maintains schedules and budgets for each phase of the project. Works with internal and external project resources to outline work plan and to assign duties, responsibilities, and scope of work.  Reviews status reports with various departments and modifies the schedules or plans as required. Prepares project reports and provides management updates.  Leads project teams with cross-functional members to achieve successful outcome.  Demonstrates ability to effectively problem solve and negotiate with others to achieve project goals.  Exhibits creative and effective ways to resolve complex issues. Utilizes professional concepts and expertise to analyze situations or data and provide meaningful evaluations. Demonstrates a thorough understanding of industry practices and company policies and procedures.  Participates as a technical subject matter expertise during internal and external meetings.

Essential Duties

• Manages and leads CapEx and continuous improvement projects, identifying set-up time reduction, inefficiencies and areas of waste in the manufacturing process.
• Manages. prepares and presents cost estimates and justifications sufficient to attain project funding.
• Manages project capital spending within established norms. Provides financial reports as required.
• Coordinates the design and construction of new facilities and facility upgrades.
• 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.
• Manages documentation program for engineering documents.
• Leads project activities and resources with a focus on critical milestones to ensure effective and timely execution of project plans.
• Investigates new equipment and technologies in the pre-planning stages of a project and determine the appropriate equipment for the application.  
• Reviews technical reports and documents for accuracy/content and approve final documents.
• Provides production support engineering for high volume production equipment used on new and existing products and processes.
• Provides technical support and solutions for manufacturing related initiatives including investigations and closures of Deviations and CAPAs.

Education / Experience Requirements

Bachelor's degree in Mechanical Engineering, Chemical Engineering or related engineering discipline. A minimum of 9 years' engineering experience in a manufacturing environment required. Experienced in cGMP Solid Oral Dose pharmaceutical manufacturing / packaging equipment, processes and facility operations strongly desired.  Project planning and project leadership and design/building construction experience strongly desired.

Other Knowledge, Skills and Abilities

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.

Certifications / Licenses

Professional Engineering license or EIT certification preferred.

Travel Requirements

Up to 25%

Constant hearing, talking and near vision. Frequent sitting (60%) and standing/moving about (40%). Occasional handling and reaching (straight out and above head). Occasionally lifts and carries up to 50 lbs. Occasional bending at the waist and squatting. Frequent exposure to loud noise and moving machinery. Occasional exposure to dust, active pharmaceutical ingredient and other chemicals. Occasional exposure to pressurized systems.

Compensation Range:

Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.