Specialist Tech Engineering

Posted 4 Hours Ago
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Juncos
Senior level
Pharmaceutical
The Role
The role involves ensuring compliance of utility systems, coordinating technical support to maintenance teams, and facilitating routine audits to maintain industry standards and regulatory compliance.
Summary Generated by Built In

 For Engineering services in the Project Management area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • 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

The Personality Part:    

  • 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!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

  • Ensure utility systems, process maintenance, instrumentation/calibration/electrical systems, and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards, and FDA standards. 
  • 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, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues, and process maintenance 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, documentation, operations, and related areas to ensure a continued state of compliance. 
  • 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.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the next piece?

Top Skills

Maximo
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The Company
HQ: Guaynabo, PR
76 Employees
On-site Workplace
Year Founded: 2008

What We Do

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!

Are We The Right Piece For You?
We are:

Experienced and knowledgeable in the Industry
Committed to Safety
Always compliant with FDA Regulations & Audits
Cost Effective
Proven successful track record
Over ten (10) years of experience

If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]

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