Validation & Engineering Group (VEG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
Validation Specialist - Process and Product
Performs, coordinates, and exercises functional authority for planning, organization, control, integration, and completion of engineering maintenance and process upgrade tasks within area of assigned responsibility. Use project management tools to achieve cost reduction results per the strategic plan on every budget process.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Coordinates activities concerned with technical developments, scheduling, and resolving engineering design and test problems.
- Directs integration of technical activities and products.
- Evaluates and approves design changes, specifications, and drawing releases.
- Controls expenditures within limitations of project budget.
- Prepares interim and completion project reports.
- Assists, trouble shoots, give technical support to all assigned equipment and personnel.
- Develops, implements systems or projects, procedures and policies to assure the compliance with cGMP's, Safety and FDA regulations.
- Creates, reviews and implements changes to specifications and SOP's.
- Audits all areas under responsibility assuring the compliance, cGDP's, specifications, and procedures.
- Supports and assists in the trouble shoot of projects and equipment as required. Lead validations process.
- Completes all documentation and reports on a timely basis as required (daily, weekly, monthly and annually).
- Able to work within minimum supervision.
- Keep and develop strong working team, manufacturing maintenance environment.
- Should be able to work at any shift when its required.
- Good and strong supervisions skills.
- Able to work with many projects and handle multiple tasks at the same time.
- Team worked oriented.
- Request and order all materials required on a timely basis to ensure an efficient performance of the department.
- Must be able to communicate effectively at all Plant Levels.
- Must be able to keep the work area in the cleanest and order conditions.
- Willing to travel.
- Willing to work extra hours, any shift or Holidays (eg. shutdowns, extraordinary events).
Directly supervises employees in the Technical Area. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
The incumbent should be able to stay uncalled during special periods as assigned by the immediate supervisor.
Ability to read, analyze, and interpret 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, clients, customers, and the general public. Fully bilingual (English and Spanish languages).
Ability to apply advanced mathematical concepts such as exponents, logarithms, 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 define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
CERTIFICATES, LICENSES, REGISTRATIONS
cGMP's Training, State Engineering license and other certificates or registrations 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.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; sit; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to climb or balance. The employee must occasionally lift and/or move up to 10 to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
While performing the duties of this job, the employee is regularly exposed to fumes or airborne particles, toxic or caustic chemicals, and extreme cold. The employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock; and vibration. 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 Baxter 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 use industrial and non industrial computerized system; manufacturing and laboratory equipment; telephone; office supply; copy machine; fax machine; computer.
EDUCATION and/or EXPERIENCE
Bachelor's degree (B.S.E.) in Engineer (Mechanical or Electrical); State Engineering License; computer knowledge.