JOB PURPOSE Responsible for Process and Product Transfers and New Product design procedure. Process and Products Validations Procedures. Process and documentation maintenance. Implementation of Value Improvements Projects (VIP). ESSENTIAL DUTIES AND RESPONSIBILITIES Manages all new or existing Process and Product related activities. Coordinates with manufacturing and quality personnel to resolve problems relative to product design, specification, materials, tooling and manufacturing operations that affect the product in form, fit and function. Responsible for developing a sound Process and Product Engineering Strategy to support the Jayuya Strategic Plan. Initiates Value Improvement Project (VIP) regarding process and product changes in order to support the Jayuya Plant VIP program. Maintains communication with all corporate divisions and groups in order to support the different product lines and attract new business to the facility. Support all validation and re-validation activities in accordance with applicable standard operating procedure (SOP), corporate specification and FDA guidelines. Coordinate the timely analysis of complaints. Responsible for the preparation and administration of the Process and Product Engineering budget. Responsible for the development, training and re-training of qualified personnel. Performs other duties as assigned. Manage new business Initiatives with international markets. Responsible for Industrial Engineering Program at the Jayuya facility. Observes all company and regulatory EHS requirements. Coordinate & Support MVDA program. EDUCATION and/or EXPERIENCE Bachelor Degree in Engineering or higher Degree on engineering fields. 7 years in managing the activities of Engineering Dept. in a regulated environment (medical device or related field). Technical management experience including cross-functional teams, resource and budget management and strategic development experience. Must possess strong knowledge of engineering disciplines (e.g. fluid flow, thermodynamics, heat transfer, static's and dynamics, engineering materials) and solid knowledge of related disciplines. Ability to establish long-range business plans which anticipate global trends, technical, economic and socio-political conditions. Demonstrate understanding of business drivers, customer needs and global dynamics to create viable strategic plan. Proven track record of management/ leadership effectiveness. Must possess strong ability to negotiate and maximize effectiveness of resources and influence others internally and externally. LANGUAGE SKILLS Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, internal or external audits and/or boards of directors. Fully bilingual (English and Spanish languages). MATHEMATICAL SKILLS Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques and factor analysis. REASONING ABILITY Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. CERTIFICATES, LICENSES, REGISTRATIONS, EXAMS cGMP's Training, State Engineering License required and other certificates, exams, registrations or licenses that the immediate supervisor refers. COMPANY REGULATORY COMPLIANCE Observe and promote company security, industrial hygiene, cGMP's, procedures and other security measures already established by the company; should inform any violation. PHYSICAL DEMANDS Sedentary Work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met WORK ENVIRONMENT While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions, fumes or airborne particles, toxic or caustic chemicals, extreme cold, and vibration. The noise level in the work environment is usually moderate. EQUIPMENT and/or SAFETY EQUIPMENT The incumbent must use the proper equipment in any Baxter area to comply with Company policies, and any internal or external regulation; or policy (eg. safety shoes, safety glasses, ear plugs, safety gloves, etc.) While performing, this job the incumbent must use: copy machine, fax machine, computer, telephone, office supply, company car, etc. DISCLAIMER STATEMENT The above statement are intended to describe the general nature an level or work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTAbaxter.com and let us know the nature of your request along with your contact information. SDL2017
Ciudad: jayuya
