Lead Equipment Engineer - Fitchburg, Wisconsin
The Payroll Company
The Lead Equipment Engineer will lead cross functional teams of Engineers, Maintenance, Facilities, Manufacturing and Vendors responsible for overseeing and executing the specification (URS), design, commissioning (FAT, SAT Characterization testing), installation, documentation and technical training for capital equipment projects. The Lead Equipment Engineer will provide Packaging Equipment Engineering technical support to all company Packaging Operations. They will improve packaging processes and equipment technologies across multiple disciplines in an effort to provide the best, most reliable packaging processes. This individual will be a Subject Matter Expert for Packaging Engineering with extensive experience in equipment installation, validation and equipment/packaging project start-ups.
1. Manage the execution of multiple engineering projects from conception through manufacturing handover. Ensure positive results for technical, financial, schedule and organizational performance.
2. Work on quotation bids and bid evaluations with the team, vendors and purchasing department.
3. Develop engineering project plans and schedule of the project tasks in conjunction with the Project Manager and/or Project Engineer (SME), depending on complexity and scope of projects.
4. Work with Engineering, Validation and QA Documentation for timely and complete development and documentation of functional system specifications, interface specifications and commissioning test plans (FAT, SAT).
5. Develop extensive plans for new equipment in order to prove out any technology risk areas or identify gaps prior to installation.
6. Coordinate progress of project teams in close cooperation with the Project Manager, working closely with internal customers and vendors.
7. Monitor and report project performance metrics, progress and status to Operations Engineering and Executive Management.
8. Ensure the creation or procurement of user manuals, documentation, training and project evaluations.
9. Identify, initiate and drive continuous improvement of production systems or resolution of operational deficiencies by leveraging process excellence tools while fostering a culture which focuses on process robustness.
10. Advise management of needed improvements for project execution processes.
11. Propose technical solutions for complex and multidisciplinary problems.
12. Perform analytical, statistical and engineering studies to support development of new equipment acquisition, improvement of packaging processes and the optimization of resource utilization.
13. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
1. Bachelor’s Degree in Engineering or equivalent experience. Mechanical or Packaging Engineering preferred.
2. 10 to 15 years of experience in project managing highly complex and large scale GMP manufacturing capital equipment projects. Pharmaceutical, Medical Device or OTC industry is preferred.
3. Demonstrated ability to effectively use project management tools, such as MS Project, Primavera, etc.
4. Demonstrated ability to develop, use, and communicate project controls for scope, budget, and Key Performance Indicators (KPIs).
5. Solid background in liquid filling equipment and sealing technologies –bottle sorting, filling, capping, labeling. Induction and heat sealing. (PLC logic and servo motor applications is a plus).
6. Excellent leadership skills and the ability to work in a cross-functional team environment are required. Excellent communication and presentation skills are required.
7. Demonstrated ability to lead and influence across the organization without direct line authority.
8. Strong analytical skills with the ability to troubleshoot and manage complexity in ambiguous time critical situations.
9. Strong decision making ability based on sound engineering and economic factors.
10. Self-motivated, proactive, hands on approach and work ethic.
11. Strong team-oriented mentality and demonstrated responsibility for project completion.
12. Pragmatic and capable of balancing GMP quality, lead time, costs and technology.
13. Ability to train and motivate team and coworkers.
14. Knowledge of AutoCAD, Solid Works, Six Sigma and Lean manufacturing desired.
15. Computer literate (MS Office and Statistical programs).
16. Up to 25% domestic travel with the potential for international travel.
Primary Skills: AutoCAD, Solid Works, Six Sigma and Lean manufacturing, GMP, PLC logic, BioTech, Pharma
Salary: Between -
Experience Required: Experienced, 10 years minimum
Clearance Level: none
Travel: 25 %
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