Process Engineer

Ultimate Solutions • Puerto Rico, PR

4d

About The Position

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.

Requirements

• Bachelor’s degree in Engineering (3 -5 years of experience)
• Experience in Medical Device or Pharmaceutical industry is required
• 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

Nice To Haves

• Project Management experience managing multi-sites project is a plus

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level