Process Engineer

Ultimate Solutions Corp is a global leader in compliance and technology solutions, specializing in end-to-end integrated services for the Life Science industry. With 19 years of experience, we have built core competencies by combining regulatory and quality expertise with advanced packaging automation, serialization, brand protection, and IT services. This unique blend of capabilities has enabled us to expand our reach to client worldwide.

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.
• Six Sigma Certification desirable

EDUCATION

Bachelor’s degree in Engineering ( 3 - 6 years of experience )

REQUIREMENTS / SKILLS

ADDITIONAL REQUIREMENTS

Ultimate Solutions Corp is an equal opportunity employer.