Undergraduate Degree in Engineering, preferred P. Eng
5-10 years in capital project engineering, specifically in OSD facilities
Demonstrated leadership and people management skills
Strong interpersonal and negotiation abilities
Deep knowledge of technical disciplines like GMP manufacturing, packaging, and utilities
Proficient in project management and engineering validation processes
Responsibilities
Lead the project engineering team in a pharmaceutical environment
Manage the lifecycle of capital equipment procurement
Oversee the site capital plan and project implementation
Develop detailed User Requirement Specifications from operational needs
Communicate project status effectively to stakeholders
Mentor staff and foster team development
Select and coordinate with external engineering suppliers and consultants
Benefits
Comprehensive health coverage including medical, dental, and vision
Retirement savings plans with employer matching contributions
Paid time off
Professional development opportunities
Employee wellness programs
Access to Employee Assistance Program and mental health resources
Full Job Description
Job Summary
Provide leadership to the project engineering team in a pharmaceutical solid oral dose manufacturing facility. Own the full lifecycle of capital equipment procurement-from initial financial modeling and vendor negotiations to engineering oversight, installation, and final cGMP qualification. Develop and mentor engineering staff.
Essential Functions
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Responsible for managing & implementing new capital projects and improvement projects
Lead Project Engineering staff, related internal resources, external engineering suppliers to develop, implement and improve GMP manufacturing and packaging related facilities, equipment and systems;
Provides engineering expertise and advice for developing technical solutions that best meets business requirements
Translate operational needs into detailed User Requirement Specifications (URS) and technical engineering designs.
Oversee the site capital plan and managing the justification, approval & implementation of the portfolio of projects
Prepare business case and capital investment proposals for recommend technical solutions to optimize manufacturing capability
Forecast and manage resource needs to deliver project plans
Communicate project status including scope, schedule, budget to stakeholders
Lead and motivate staff to develop & deliver the optimal technical solutions that meet the business needs
Select and manage professional consultants, contractors and suppliers
Manage relationships with customers, vendors and above-site resources to set expectations and communicate progress
Ensure that compliance issues and regulatory audit questions are addressed
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.
Minimum Education, Experience and Skills
Undergraduate Degree in Engineering, P. Eng preferred
5 - 10 years in project engineering (capital equipment related)
Proven experience managing capital projects in solid oral dose (OSD) facilities
Excellent people management skills
Demonstrated interpersonal, leadership, negotiation, organization and communications skills
Ability to understand significance of emerging technology and their application to meeting business goals
Detailed knowledge of multiple technical disciplines (including: Facilities, Critical Utilities, Construction, Manufacturing, Packaging, and Computer & Automated Systems) and ability to apply these practices in addressing issues at work
Strong skills & knowledge in: project management, control systems, equipment & process engineering and validation
Preferred experience related to information and distributed system analysis, design, integration and implementation
Knowledge of HPB, FDA, GAMP, IEEE & PMBOK standards
Proficient in MS Office, SAP, CMMS and other similar software
Salary Range: 108,000-150,000
Compensation and Benefits
We offer a comprehensive benefits package designed to support our employees' wellbeing, including:
Competitive salary and performance-based incentives
Comprehensive health coverage including medical, dental, and vision insurance
Retirement savings plans with employer matching contributions
Paid time off
Professional development opportunities
Employee wellness programs and resources
Employee Assistance Program and Mental Health Resources
About Upsher-Smith
Upsher-Smith Laboratories, LLC is a pharmaceutical company headquartered in Maple Grove, Minnesota. The company was founded in 1919 and is now a subsidiary of Sawai Pharmaceutical Co., Ltd. Upsher-Smith develops, manufactures, and markets prescription and over-the-counter products in the areas of women's health, dermatology, cardiology, and neurology. The company has a strong commitment to quality and innovation, and is dedicated to improving the health and well-being of patients.
