Engineer

FITS, LLC; Carolina (PR); On-site; USD 55,000 - 75,000; Full time

Job summary

FITS, LLC is seeking a qualified engineer with fermentation manufacturing experience to support validation, equipment operations and process improvements.

You will collaborate with multiple teams to ensure proper execution of procedures, documentation and CAPA-related activities, while maintaining safety and compliance standards across our island and US operations.

Qualifications

• Bachelor's degree in Engineering and at least 2 years in validation in Medical Device or Pharma.
• Bilingual Spanish and English (verbal/written).
• Shift: Administrative as needed by business.
• Experience in investigation and documentation.
• Experience in approval management, and coordinating meetings for Warehouse dept.
• Ability to optimize processes across Warehouse, Incoming, and Dispatch.

Responsibilities

• Understand basic scientific and engineering principles for fermentation manufacturing processes.
• Translate process requirements into field execution per operational instructions.
• Review production instructions and co-own preparation, revision and approval of instructions.
• Provide technical support for troubleshooting and countermeasure implementation.
• Perform fermentation tasks (discharge tanks, material handling, raw material charges, cleaning, in-process testing).
• Support daily operations management with 24/7 technical support.
• Attend Process Team meetings and weekly huddles.
• Understand how equipment impacts process parameters and control strategies.
• Lead or support documentation related to equipment events, CAPAs and changes.
• Provide technical expertise for installation, operation, maintenance, and reliability of pilot plant equipment.
• Oversee Process Validation and related equipment, facilities, and computer systems; assist with PM plans and spare parts; prepare verification documents.

Skills

Bilingual: Spanish/English

Investigation

Documentation

Approval management

Meeting coordination

Process optimization

Problem solving

Quality/compliance awareness

Education

Bachelor's degree in Engineering

Job description

WHAT MAKES YOU A FIT

• Bachelor's degree in Engineering and at least two (2) years of experience in validation activities within the Medical Device or Pharmaceutical industry.
• Bilingual: Spanish and English (verbal / written)
• Shift: Administrative and according to business needs.
• Experience in:
  • Investigation and documentation.
  • Approval management, and meeting coordination for the Warehouse department.
  • Optimize processes and equipment across Warehouse, Incoming, and Dispatch operations.
  • Identify opportunities for improvement, resolving problems.
  • Investigate observations and incidents.
  • Contribute to training initiatives and implement process changes.

The Technical Part

The Technical Part:

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 of 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

• 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 serve as the co-owner in the preparation, revision and approval of operational instructions.
• Provide technical support for 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!