Project Engineer II

We are hiring for a Project Engineer II in Minneapolis, MN. The Project Engineer II is a key member of the engineering team, responsible for coordinating technical aspects of project execution, ensuring that all engineering-related activities are performed in accordance with company standards, contractual agreements, and engineering best practices. This role requires a combination of technical expertise, leadership skills, and project management experience.

Job duties:

• Lead and manage capital projects that will support formulation and manufacturing activities for new and existing products. Projects to support continuous improvement, capacity expansion, new product development, safety, and compliance.
• Uses effective engineering project management skills, including scope definition, project planning, implementation, budgeting, and scheduling. Develop and maintain project documentation, such as project outlines, Gantt charts, progress reports, and cost tracking reports.
• Drafts user requirements specifications by working with impacted individuals to understand equipment/product needs, leads project execution, and drafts/executes equipment qualification/testing procedures.
• Create and update GMP documentation as needed by the project, including, but not limited to, equipment qualifications, change controls, standard operating procedures, equipment manuals, etc.
• Applies standard engineering techniques to troubleshoot moderate to complex problems. Collaborates with engineering, operations, and maintenance to provide and implement solutions to remediate these issues.
• Ensures successful completion of the assigned project phase within the budgeted time and cost constraints.
• Collaborates and leads with cross-functional teams, including operations, quality, construction, procurement, external vendors, and others as needed to ensure project success. Provides timely and accurate updates to impacted individuals.
• Champion the use of continuous improvement.
• Performs other Tasks as assigned.

Minimum qualifications:

• Bachelor's degree required, preferably in Engineering or related science.
• Four or more (4+) years of work experience required, with a proven track record of successful project completion.
• Excellent project management skills.
• Strong interpersonal, writing, and oral communication skills. Ability to work with cross functional teams and external vendors.
• Strong technical writing skills.
• Ability to work in an FDA regulated environment.
• Periodic Domestic and International travel may be required.
• Strong analytical, problem-solving, and decision-making capabilities. Understanding of engineering theory and fundamentals of equipment operation. Demonstrated use of engineering principles, theories, concepts and techniques.
• Ability to react to new demands, priorities, and challenges or obstacles in a resourceful and constructive way.

Preferred qualifications:

• Experience working in pharmaceutical manufacturing or related manufacturing field preferred.
• Proficient in Microsoft Office. AutoCAD software experience preferred.