Process Engineer

For Engineering services in the Fermentation Plant area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in Engineering (Chemical or Mechanical) and at least two (2) years of experience in Computer systems validation activities within the Medical Device or Pharmaceutical industry.
• Bilingual: Spanish and English (verbal/ written)
• Shift: Administrative and according to business needs.
• Experience in:
  • Fermentation processes
  • Managing multiple projects and prioritizing work based on business needs
  • GMP & GDP regulations.
  • Technical and quality documentation 

The Personality Part:    

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're 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.
• Perform tasks related to fermentation process (i .e. discharge tanks, material handling, raw material charges, equipment cleaning, in-process testing, etc. )
• 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 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?