Manufacturing Validation Engineer

Relevant Experience

(in Yrs)

4+ years of experience & demonstrated proficiency in manufacturing validation & providing ongoing technical support is preferred with evidence of continued self-development.

Work experience in the Medical Device industry.

• Technical/Functional Skills

• Knowledge of Medical Equipment manufacturing processes
• GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 9000 and regulatory affairs
• Ability to specify & qualify Assembly, Tooling, Gage equipment and Fixture equipment
• Knowledge in the areas of Process validation, Statistical process control, Product design & DFMA (Design for Manufacturing & Assembly), Plastic & metallic materials & processing and Applied Statistics
• Knowledge of biocompatibility in medical device industry
• Demonstrated ability to interpret the engineering drawings i.e., GD&T (Geometric Dimensioning &Tolerancing)
• Understanding of Process development & design and Quality Function Deployment
• Excellent Analytic problem solving, Broad business planning, Cross-functional integration skills
• Demonstrated understanding of Ergonomics and financial analysis skills preferred
• Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
• Understanding of Marketing & market research strategies
• Personal computer skills, Windows: word processing, project planning,
• presentation, e-mail, web browsers & spreadsheet software
• Training & experience in Good Manufacturing Practices & ISO 9000 is required.

Experience Required

4+ Years

Roles & Responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the duties and responsibilities for this position are:

• Train mechanics & operators on internal processes & equipment requirements
• Perform Installation Qualification, Operational Qualification, Process Qualification
• Develop validation protocols, qualify first articles, complete process capability studies & process validation on both internal & supplier processes using appropriate statistical techniques
• Prepare reports as per project requirement
• Actively participate in setting overall project objectives, direction & contributing in

other functional areas as needed

• Work with R&D as needed to support process development, process improvements and process transfer activities
• Can travel to plant site at Mexico if required
• Know & follow policies & procedures related to work activities performed

in area of responsibility

• Complete training in area of responsibility within allowed time-period and periodic retraining in areas such as safety & environmental
• Follow all company safety policies & other safety precautions within work area.

Generic Managerial Skills
Strong communication skills. Candidates must be highly proficient in reading, writing, and speaking English language.
Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
Ability to understand and follow complex written procedures is required.