Lead new and existing products change implementation review, from process evaluation through FDA approval and products launch. Execute all related activities to new products introduction and product changes and Change Control procedures. Assures that the Company complies with all internal and external standards and regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Provide technical support to Manufacturing, Engineering and Quality areas for the manufacturing environment of parenteral solutions and medical devices. Manage all New Product introduction and Product Change Controls related activities with corporate and internal plant resources, to meet milestones and deadlines. Participate on the evaluation of customer requirements for New Products and provide suggestions for process/product improvements. Gets involved and/or lead company teams such as: New Products Team, Change Control Review Board, etc. Lead a functional team for special projects. Includes perform team meetings, track progress, action items and deliverables. Report results to management as required by supervisor. Implementation of manufacturing projects developing timelines and periodic meetings to report projects progress and implementation strategies in order to meet deadlines. Provides technical information concerning processing techniques, materials, properties, and process advantages and limitations which affect long range plant and product engineering planning. Assists and support in the trouble shoot of projects as required. Able to handle multiple tasks at the same time. Willing to work extra hours, any shift or Holidays (e.g. shutdowns, extraordinary events). Must be able to keep the work area in the cleanest and order conditions. Team worked oriented, active participation in Company teams when required. Review validation protocols and reports for the qualification of manufacturing process, equipment's and process changes as necessary. Implements changes and follow-up actions to ensure the effectiveness of the changes. Interface with other Client's plants and Divisional groups when required. Support manufacturing/quality functions (Documentation, Laboratories, Process, Engineering) in the preparation and development of new products process and batch release related to FOC / Protocols. Able to work with minimum supervision. Should be able to work with multiple projects and handle multiple tasks at the same time. Teamwork oriented. Communicate effectively at all Levels.
EDUCATION and/or EXPERIENCE
Bachelor’s degree in Engineering, Natural Sciences or Bachelors degree with manufacturing experience minimum of 5 years experience in product development, change control, validations or related areas; Master degree or PhD with at least 2-3 years of experience will be equivalent.
Ability to discuss normally encountered technical or project management issues, both verbally and in written form. Ability to work as a collaborative team member with good negotiations skill. Ability to solve routine design, engineering problems with assistance. Skills in MS Project/MS Excel and Word applications to do process analysis and technical reports. Knowledge of problem-solving and statistical techniques. Good interpersonal skills. Traveling is required.
Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, internal or external audits. Fully bilingual (English and Spanish languages). Ability to communicate at any Plant level.
Ability to apply advanced mathematical concepts such as exponents, logarithms and quadratic equations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
CERTIFICATES, LICENSES, REGISTRATIONS
cGMP's Training, and other certificates, exams or licenses that the immediate supervisor refers.
COMPANY REGULATORY COMPLIANCE
Observe and promote company’s security, industrial hygiene, cGMP's, procedures and other security measures already established by the company; should inform any violation.
While performing the duties of this job, the employee is regularly required to stand to sit and talk or hear. The employee is occasionally required to walk, use hands handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and color vision.
While performing the duties of this job, the employee is regularly exposed to wet and/or humid conditions, fumes or airborne particles, toxic or caustic chemicals, extreme cold, risks of electrical shock, high, precarious places; extreme heat; and vibration. The employee is occasionally required to move mechanical parts; The noise level in the work environment is usually moderate.
SAFETY EQUIPMENT and/ or EQUIPMENT
The incumbent is required to use the appropriate safety equipment that the Client requires to comply with all Safety and Security rules (in Regulated Areas), such as: safety glasses, safety shoes, special safety suit, gloves, and any other equipment necessary in order to protect the health and safety of the incumbent. The incumbent must be proficient in industrial and nonindustrial computerized system; manufacturing and laboratory equipment and / or machinery; telephone; office supply; copy machine; fax machine; computer.
The above statements are intended to describe the general nature and 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.