We are seeking a Maintenance Engineer to provide advanced engineering, packaging, process and manufacturing equipment support for complex production and processing equipment. Develops process excellence techniques to identify systematic issues. Tracks trends, develops and implements equipment and/or process enhancements that will improve efficiency, product yield, and equipment reliability. The candidate must have solid GMP and regulatory experience.
Duties and Responsibilities:
Skills and Specifications:
- Leads in troubleshooting and resolving equipment, systems, and process problems to prevent the occurrence of product and process non conformities.
- Ensures that process and material quality objectives are met.
- Establishes process and material quality targets.
- Reviews performance measurements to targets and provides remedial action directives.
- Generates capital equipment appropriations required for new process implementation and controls expenditures to ensure compliance with timing and budget requirements. .
- Leads new processes and equipment analysis.
- Develops process documentation and maintains training material on processes, materials, and equipment.
- Keeps up to date systems and technology.
- Participate in process/product troubleshooting.
- Recommends and implements measure to improve production methods, equipment performance, production floor layout, yields, and quality of product.
- Practical application and working knowledge of project management, cost/benefit analysis, and statistical skills required.
- Ability to read, analyze, and interpret common scientific, technical and financial reports.
- Candidates must have flexibility to support processes in various shifts and workdays per the operational needs.
- Experience with equipment qualifications, factory acceptance testing, commissioning, CSV, root cause analysis and validations.
- Process and or packaging engineering and equipment (Press machines, Fluid Bed Dryers, High Shear Mixers, Coating Pans, Printers, Bottle and blisters lines) upgrade / maintenance support experience highly desirable
- Fully bilingual (Spanish/English).
- Four to seven years in a similar technical position within the pharmaceutical / Medical Device manufacturing industry required.
Bachelor’s in Engineering (BSME, BSEE, BSChE, BSIE preferred)
- Problem Solving
- Sense of urgency
- Detail Oriented
- Be flexible enough to travel to job sites when need arises.
- Able to work with minimum or no supervision
- Strong interpersonal skills and must work in a team
Ultimate Solutions Corp is an Equal Opportunity Employer.