Senior Commissioning & Qualification Lead

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

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.