RESUMEN GENERAL (SUMMARY):
This person will oversee the compliance with all the regulatory requirements related to the Critical Systems. Critical Systems will include the following equipment or systems: Water for Injection (distribution piping, pumps, stills, WFI storage tank, heat exchangers), Reverse Osmosis, Carbon Filters, Water Softeners, Chlorine Injection, Process Water Storage Tanks and Pumps, UV Light, Deep Well, Boilers, Manufacturing Air Conditioning, Compress Air and Vacuum.
TAREAS Y RESPONSABILIDADES (DUTIES AND RESPONSIBILITIES):
- Reviews and approves all documentation generated and verifies the accomplishment of them to the company policies.
- Executes projects, protocols, presentations and other assigned duties related to the area.
- Reviews changes in specifications (Certification Document Reviews-CDRs) and compliance with local SOP’s.
- Conducts investigations looking for root causes of non-conformances. Generate change controls and CAPA events.
- Fill out department reports such as calibration, study documents, particles, etc.
- Assists the supervisor in ln looking for improvements to optimize workload, efficiency, coordination and compliance to specifications and gap assessments.
- Assists to coordinates all sterilizer qualifications.
- Coordinates department tasks according with plant needs and department efficiency.
- Assists and maintains calibration standards and update other equipment to keep an efficient operation work area.
- Provides technical support to all activities of senior technicians, technicians and technologists and others.
- Maintains full compliance with cGMP’s and other plant regulations.
- Assures the continuity and develop of projects that the immediate supervisor assigns.
- Willing to work under minimum supervision and non- regular hours.
- Capable of work under pressure.
- Assist the immediate supervisor when requested.
- Able to handle multiple projects and tasks at a time.
- Observe all company and regulatory EHS requirements.
- Observe data privacy and confidentiality rules at all time.
- Will assist the supervisor in calibration, environmental, utilities and sterilization documentation review and approval.
- Assures compliance of procedure related to utilities maintenance.
- Coordinates work with contractors in order to perform maintenance to critical utilities system.
- Information organization and data analysis for compliance assessment, audits and investigations.
- Assist in area procedure robustness in regards to regulatory agency current expectations.
- Responsible for developing and executing validation activities and projects as required.
- Assist the Boiler Room Engineer in performing all activities related to calibrations, environmental tests, sterilization studies and critical systems compliance with legal and regulatory standards.
- Constant interaction with plant superintendents, facilities engineer and production areas supervisors due to maintenance services planning and building corrections
DEMANDA FISICA (PHYSICAL DEMANDS):
Medium Work: Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. Physical demands requirements are in excess of those for Light Work. Able to climb stairs and vertical ladders.
While performing the duties of this job, the employee is occasionally exposed to extreme heat and moderate noise levels.
Ability to solve practical problems and deal with a variety of concrete variables in situation where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Computer knowledge a must (Word, Excel, Power Point, etc.) Able to write routine reports and correspondence. Ability to speak and present information effectively before plant groups meetings.
Fluently in English and Spanish languages
EDUCACIÓN Y/O EXPERIENCIA (EDUCATION AND/OR EXPERIENCE):
B.S degree in electrical, mechanical, chemical or industrial engineering. Three to five years of experience in facilities/utilities maintenance.
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
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_TTA@baxter.com and let us know the nature of your request along with your contact information.