Summary: Seeking a Process Engineer to lead and support projects, drive improvements, and ensure compliance in life science industrial automation. Highlights: 1. Lead/support projects in new product and technology introductions. 2. Drive improvements through process trend evaluation (Yield, OEE). 3. Develop and revise production standards and manufacturing processes. Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over a decade, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices, and logistics markets. **Process Engineer** **RESPONSIBILITES** * Lead/support projects or initiatives, including but not limited to: new products, process and technology introductions. * Participates in projects involving other departments and activities. * Coordinates communications and interact within end users and machine manufacturers or suppliers. * Evaluates process trends (Ex. Yield, OEE) to drive improvements of business results. * Responsible for problem identification, root cause analysis, project management, financial analysis, efficiency or productivity improvement, and problem resolution. * Support process improvement projects that have the objectives of developing more cost efficient and quality enhanced processes. * Evaluate data generated through studies using statistical analytical methods. * Responsible for the development and/or revision of production standards and Manufacturing/Packaging process to assure utilization of best process. * At higher levels, may lead and direct the work of others. * Build and execute validation strategies. * Must possess a solid understanding of FDA Validation guidelines. * Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards. * Generate new specifications based on new regulations required by the implementation of a new manufacturing process. * Generates, executes, reviews, and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. * Prepares and coordinate qualification activities. * Communicate with the staff and management on ways of implementing plans and recommendations. * Responsible for designing, document and implementing manufacturing and/or packaging processes \& equipment. * Familiar with a variety of field concepts, practices, and procedures. **EDUCATION** Bachelor’s degree in Engineering (3 \-5 years of experience) **REQUIREMENTS/SKILLS** * Experience in Medical Device or Pharmaceutical industry is required * Project Management experience managing multi\-sites project is a plus * GMP \& ISO knowledge, understanding and experience * Computer skills and use of software application(s). Strong computer background (MS Office, MS Project Management, Word, Excel, Outlook, etc.) * Strong knowledge on statistics, problem solving and lean tools. * Effective interactions in a team environment * Team player, self\-starter, persistent, tactful, and persuasive * Good organizational skills, detail\-oriented \& accurate, analytical skills * Effective verbal and written communication skills (writing and presentations) * Able to work with minimum or no supervision * Fully Bilingual (English and Spanish) **ADDITIONAL REQUIREMENTS** * Must have knowledge in: Process Validations, Equipment Validations, Equipment Qualifications, Test Method Validations. Manufacturing Procedures generation, Component Qualification, QE, experience with documentation, reviewing and approving IQ, OQ, PQ. * Technical Writing Skills *Ultimate Solutions Corp is an equal opportunity employer.*