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Process Engineer
New!Ultimate Solutions Puerto Rico , PR
Posted Today
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 EngineerRESPONSIBILITES
- 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.
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)
- 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
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