Senior Process Engineer — Pharma, AI/Automation Focus

fitspr; Juncos (PR); On-site; USD 90,000 - 125,000; Full time

Job summary

FITS is seeking an experienced Process Engineer to join our team in Juncos, Puerto Rico. The role focuses on advancing pharmaceutical and medical device processes within a regulated environment, delivering new engineering techniques and compliant procedures.

You will lead a small engineering team, coordinate with manufacturing, QA, and utilities, and develop budgets while applying advanced engineering methods to complex problems. Strong bilingual communication is required in English and Spanish.

Qualifications

• Bachelor's Degree in Engineering and 4 years of process experience in regulated industry.
• Bilingual English and Spanish required.
• Experience in Drug Product Manufacturing and characterization processes.
• Familiar with Qualification and Validation lifecycle.
• Proficient with automation tools like Python, Codex, Power Automate, SQL, or VBA.

Responsibilities

• Develop new or improved engineering techniques and procedures.
• Develop engineering policies and procedures affecting multiple units.
• Supervise and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
• Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
• Application of mature engineering knowledge in planning and conducting projects.
• Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
• Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project

Skills

Project Management

Engineering

Bilingual English/Spanish

Team Leadership

Education

Bachelor's Degree in Engineering

Tools

Python

Codex

Power Automate

SQL

VBA

Job description

FITS is seeking an experienced Process Engineer to join our team in Juncos, Puerto Rico. The role focuses on advancing pharmaceutical and medical device processes within a regulated environment, delivering new engineering techniques and compliant procedures.

You will lead a small engineering team, coordinate with manufacturing, QA, and utilities, and develop budgets while applying advanced engineering methods to complex problems. Strong bilingual communication is required in English and Spanish.