Job SummaryProvide 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 FunctionsReasonable 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 BenefitsWe 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
