JOB OBJECTIVE: The Lead Equipment Engineer will be responsible for supporting the manufacturing team with automated equipment solutions for the dispensing and final packaging of saleable products. This role will work with management to develop an equipment asset strategy and lead the execution of the strategy. This position will be required to work with cross functional teams of Engineers, Maintenance, Facilities, Manufacturing and Vendors in the development and execution of specifications (URS), designs, commissioning (FAT, SAT Characterization testing), installations, documentation and technical training for capital equipment projects.
The position will provide Packaging Engineering technical support to all Promega’s Packaging Operations. Additionally the Lead Equipment Engineer will improve packaging processes and equipment technologies across multiple business units in an effort to provide the best, most reliable packaging processes. This individual will be a Subject Matter Expert for Operations Engineering with extensive
experience in equipment installation, continuous improvement and equipment/packaging project start-ups and use this expertise to establish standards and mentor other engineers in the department.
1. Manage the execution of multiple engineering projects from conception through manufacturing handover. Ensure positive results for technical and operational performance.
2. Assist operations management in the development of the equipment asset strategy and lead the execution of the strategy within Operations Engineering.
3. Develop project plans and schedule, including extensive plans for new equipment in order to prove out any technology risk areas or identify gaps prior to installation.
4. Direct the request for quotation bids and lead bid evaluations with the project team and purchasing department in the selection of equipment vendors.
5. Develop system specifications (URS), trace matrix, factory acceptance testing (FAT), site acceptance testing (SAT) and documentation required by validation for new equipment installations with assistance from Validation, QA Validation and project team.
6. Lead project team, Validation and QA Validation in the review of vendor supplied documentation for timely and complete development of functional requirement specifications (FRS), hardware requirement specification (HRS) and software requirement specification (SRS) for new equipment purchases.
7. Coordinate progress of project teams in close cooperation with the Engineering Manager, working closely with internal customers and vendors.
8. Monitor and report project performance metrics, progress and status to Operations Engineering and Executive Management.
9. Ensure the creation or procurement of user manuals, documentation, training and project evaluations.
10. 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.
11. Advise management of needed improvements for project execution processes.
12. Propose technical solutions for complex and multidisciplinary problems.
13. Perform analytical, statistical and engineering studies to support development of new equipment acquisition, improvement of current processes and the optimization of resource utilization.
14. Acts as a mentor in developing the key criteria skills of other engineers.
15. Leads development and maintenance of the functional and corporate standards for engineering and equipment related subjects.
16. Supports Health & Safety programs and cGMP initiatives and understands and complies with ethical, legal and regulatory requirements applicable to our business.
1. Bachelor’s Degree in Engineering or equivalent experience. Mechanical Engineering preferred.
2. At least 10 years of experience in specifying, FAT and SAT testing and installation of packaging equipment. Pharmaceutical, Medical Device, OTC or Food & Beverage industry is preferred.
3. Demonstrated ability to develop, use, and communicate project controls for scope, budget, and Key Performance Indicators (KPIs).
4. 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).
5. Excellent leadership skills and the ability to work in a cross-functional team environment are required. Excellent communication and presentation skills are required.
6. Demonstrated ability to lead and influence across the organization without direct line authority.
7. Strong analytical skills with the ability to troubleshoot and manage complexity in ambiguous time critical situations.
8. Strong decision making ability based on sound engineering and economic factors.
9. Self-motivated, proactive, hands on approach and work ethic.
10. Strong team-oriented mentality and demonstrated responsibility for project completion.
11. Pragmatic and capable of balancing GMP quality, lead time, costs and technology.
12. Ability to train and motivate team and coworkers.
13. Knowledge of AutoCAD, Solid Works, Six Sigma and Lean manufacturing desired.
14. Computer literate (MS Office and Statistical programs).
15. Up to 25% domestic travel with the potential for international travel.
1. Ability to observe and inspect equipment and operations for proper operation and compliance to safety and housekeeping standards.
2. Ability to work in a production environment around automated equipment.
3. Ability to work in an office environment utilizing a computer workstation.
4. Ability to travel by car or airplane, for one or several days, to suppliers, equipment vendors, trade shows, etc.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.