Equipment Reliability & Process Support Engineer

For Quality services in the Engineering area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelors degree in Engineeringand at least two (2) years of experiencein validationactivities within the Medical Device or Pharmaceutical industry.
• Bilingual: Spanish and English (verbal/ written)
• Shift: Administrative and according to business needs.
• Experience in:
  • Ensuring that material dispatch equipment to manufacturing operates under optimal conditions.
  • Coordinatingwith different departments to ensure that processes and equipment operate in an aligned and efficient manner.
  • Identifying and coordinating the personnel who will carry out equipment repairs or improvements.
  • Conducting investigations and update documentation as necessary.

The Personality Part:

• Our Next Piece is someone who treats everyone they meet like family especially our resources clients and team other words being a customer service pro is one your (many) talents. Being the Piece means youre full of bright ideas and eager to innovate always bringing top-quality results to the table. Are you ready to take on this new challenge

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

• Understand the basic scientific and engineering principles required for fermentation manufacturing processes.
• Understand how process requirements as established in operational instructions procedures process flow documents etc. translate into field execution.
• Review production instructions and serves as the co-owner in the preparation revision and approval of operational instructions.
• Provide technical support for the operational troubleshooting and implementation of identified countermeasures.
• Provide support to the management of daily operations including 24hr/7days technical support
• Attend and participate in Process Team meetings/Weekly Huddles.
• Have understanding of operational control strategy and how the equipment impacts key process parameters.
• Lead/Support execution and technical documentation related to Equipment related Events Corrective Actions Preventive Actions (CAPAs) and Changes as applicable.
• Provide technical expertise for installation operation maintenance and reliability of pilot plant process equipment.
• Have holistic understanding of Process Validation (and associated equipment facilities and computer systems) assessment of significant changes maintenance and other interventions involvement with Preventive Maintenance (PM) Plans and spare parts list. Assist in preparation of verification documents participate in the execution of the activities and support the approval.
• Makes decisions within guidelines and policies and ensures compliance with all requirements policies and regulations.
• Ensure safety processes (procedures training and equipment) are in place (i.e. Lockout/Tag Out LOTO Line breaking etc.) for pilot plant activities.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys 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 industryclients with top-notch quality talent.Were FITS!

Are you the Next Piece