Job Description

• 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.

• 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