
Specialist Tech Engineering
Flexible & Integrated Technical Services
- Juncos, PR
- Permanente
- Tiempo completo
- Bachelor's Degree with five (5) years of experience as an Engineer within the pharmaceutical or regulated industry.
- Bilingual (English & Spanish).
- Project Management skills.
- Shift: Administrative and according to business needs.
- Experience in:
- MAXIMO
- Data Entry and Data Sheets
- Job Plans
- Drawings
- Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!
- Ensure utility systems, process maintenance, instrumentation /calibration/electrical systems, and technical cleaning systems.
- Ensure the maintenance team training program, standard operating procedures, and equipment/system operational standards are consistent throughout the team.
- Coordinate technical support to the maintenance team on engineering issues, regulatory issues, compliance issues, calibration issues, quality issues.
- Provide technical support for the maintenance team during FDA and other regulatory agency inspections.
- Provide technical support to the maintenance team in response to the FDA and other regulatory agencies.
- Support the maintenance team when responding to high-purity water systems and environmental monitoring alert/action notifications.
- Support the investigation on all alert/action notifications.
- Support the development and maintenance of an audit program for the maintenance team and facilitate routine audits of activities.
- Assist plant engineering in evaluating and implementing engineering improvements, policy changes, compliance improvements, and optimization programs.
- Evaluate sanitization and maintenance procedures.
- Propose changes to the Department Manager.
- Propose process, utility, and clean room system modifications to the Plant Engineering Group.