Commissioning & Qualification Lead (C&Q)

FITS, LLC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

FITS, LLC is seeking a qualified Validation Engineer in Puerto Rico to lead validation activities across engineering systems in the pharmaceutical sector. The role covers commissioning, qualification, technical writing, and protocol drafting to ensure compliant execution.

You will review deviations, develop cross‑functional validation policies, and supervise engineers and technicians while applying advanced techniques to support complex process and facility modifications.

Qualifications

• Bachelor's Degree in Science or Engineering with five (5) years of experience in the validation life cycle, within the pharmaceutical industry.
• Bilingual (English & Spanish).
• Shift: Administrative, and according to business needs.
• Experience in: Generation & Execution Protocols Commissioning, Qualification, and validation; Develop validation engineering policies and procedures; Project Management.

Responsibilities

• Validation, Commissioning Qualification, Technical Writing, Protocol Drafting.
• Review and Execution of deviation processes.
• Develop validation engineering policies and procedures that affect multiple organizational units.
• Supervise, coordinate, and review the work of a small staff of engineers and/or technicians on an ongoing basis and on a project basis.
• Employ advanced validation engineering techniques and/or modifications of advanced techniques within the area of validation engineering expertise.
• Apply knowledge of validation engineering principles and practices outside of the area of expertise to a broad variety of assignments in related fields.
• Develop technical solutions to complex problems that require regular ingenuity and creativity.
• Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.

Skills

Bachelor's degree in Science/Eng

Bilingual English/Spanish

Validation engineering

Project management

Education

Bachelor's degree in Science or Engineering

Job description

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree in Science or Engineering with five (5) years of experience in the validation life cycle, within the pharmaceutical industry.
• Bilingual (English & Spanish).
• Shift: Administrative, and according to business needs.
• Experience in:
  • Generation & Execution Protocols Commissioning, Qualification, and validation.
  • Develop validation engineering policies and procedures.
  • Project Management

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)

• Validation, Commissioning Qualification, Technical Writing, Protocol Drafting.
• Review and Execution of deviation processes.
• Develop validation engineering policies and procedures that affect multiple organizational units.
• Supervise, coordinate, and review the work of a small staff of engineers and/or technicians on an ongoing basis and on a project basis.
• Employ advanced validation engineering techniques and/or modifications of advanced techniques within the area of validation engineering expertise.
• Apply knowledge of validation engineering principles and practices outside of the area of expertise to a broad variety of assignments in related fields.
• Develop technical solutions to complex problems that require regularingenuity and creativity.
• Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications.

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 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 industryclients with top-notch quality talent.We\'re FITS!

Are you the Next Piece?