JOB OBJECTIVE: Provide expertise in engineering, design, installation, operation and continuous improvement of production equipment (including filling, capping, torqueing, labeling, sealing, vision inspection, robotic packaging, and secondary packaging). Apply advanced problem solving and project management skills to support rapid business growth, cost reduction efforts, resource utilization, process efficiency and reliability of operations. This role will work closely with cross-functional teams including Engineers, Maintenance, Facilities, Manufacturing, Quality, Validation, and vendors in the execution of projects.
1. Process Improvement - Investigate and analyze existing manufacturing processes for on-going continuous improvement in the areas of reliability, cost, throughput, capability, efficiency, workflow, and overall resource utilization. This engineering role will support the existing filling and packaging areas in manufacturing to maximize up time of equipment while ensuring product quality. Support manufacturing operations by identifying, initiating and driving continuous improvement or resolution of operational deficiencies of process, filling and packaging operations by leveraging process excellence tools while fostering a culture, which focuses on process robustness.
2. Proactive Problem Solving - identify equipment performance and process issues and either resolve them or propose timely recommendations to management for resolution.
3. Equipment Selection - Perform financial justification analysis, write equipment specifications (URS), evaluate bids, make vendor recommendations, manage fabrication, test (FAT, SAT, and commissioning) and successfully install and start-up (including supporting process validation) new production equipment. Act as technical vendor liaison in development of equipment specifications. Travel to vendors to observe and audit production runs, processes, and specifications.
4. Equipment Fabrication - design, assemble, install and validate custom manufacturing, dispensing and packaging equipment as a cost effective alternative to vendor built systems.
5. Project Management - Lead or facilitate cross-functional teams to develop project or program objectives, evaluate alternative approaches, and develop plans and timelines from conception through manufacturing handover. Communicate and present project status reports to management and company personnel. Monitor project progress and work with team members and management to address issues. Develop project plans and schedule of the project tasks, including extensive plans to prove out any technology risk areas or identify gaps prior to installation for assigned projects. Ensure positive results for technical, financial, schedule and organizational performance, while ensuring that projects are on budget.
6. Quality - Apply quality engineering, statistical analysis, and experimental design techniques to perform root cause analysis for resolution of chronic production problems. Perform process capability studies, set specifications for in-process inspection, and perform process validation studies.
7. Cost Reduction - Work with area supervisors and suppliers to implement targeted cost reductions across Operations.
8. Documentation – Author, comment, and approve equipment documentation including system specifications (URS, FRS, HRS, SRS), trace matrix, factory acceptance testing (FAT), site acceptance testing (SAT), Validation documentation (IQ, OQ, PQ), pFMEA’s, spare parts lists, preventative maintenance instructions, standard operational procedures, and Equipment Change forms required to support new and existing equipment with assistance from cross functional teams. Ensure vendor provided documentation is obtained per Promega requirements. Store approved documentation in proper controlled systems (EtQ, SAP, ePDM). Work with Engineering resources to set up and update equipment structure and parts in enterprise system (SAP).
9. Monitor and report project and equipment performance through metrics, progress and status to Operations Engineering and Executive Management.
10. Provide training to supervisors, operators, and electro-mechanical technicians (EMT) as needed.
11. Supports Health & Safety programs and cGMP initiatives and understands and complies with ethical, legal and regulatory requirements applicable to our business.
12. Understand and comply with applicable ethical, legal and regulatory requirements.
1. Bachelor’s Degree in Engineering or equivalent experience. Mechanical, Chemical, or Electrical Engineering preferred.
2. 5 to 10 years of equipment based engineering experience in a manufacturing environment in the biotech, pharmaceutical, diagnostics, food, or chemical industry. Experience in an ISO, FDA GMP, or USDA regulated environment preferred.
3. Experience in executing GMP manufacturing capital equipment projects.
4. Familiarity with mechatronic system design: pneumatics/hydraulics, control systems, motion control, PLC programming.
5. 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. Communication (written and verbal) and presentation skills are required.
7. Strong analytical skills troubleshooting and managing complexity in ambiguous time critical situations providing strong decision making skills using sound engineering and economic factors.
8. Strong team-oriented mentality and demonstrated responsibility for project completion.
9. Project management experience.
10. Ability to train production staff and coworkers.
11. Computer aided design (3D solid modeling and 2D drafting) experience and proficiency with specific experience with AutoCAD and Solidworks preferred.
12. Computer literate (MS Office and Statistical programs).
13. 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 in a production environment around automated equipment.
2. Ability to work in an office environment utilizing a computer workstation.
3. 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.