Candidates must possess an experience in the medical devices industries. The candidate must have solid GMP and regulatory experience with expertise in equipment validations and new product transfer.
Bachelor’s in Engineering
More than 2 years of directly related experience
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
Minimum of 6 years of experience in engineering field for manufacturing environment.
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
Ultimate Solutions Corp is an equal opportunity employer.