Sr. Process Engineer - Drug Product

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

WHAT MAKES YOU A FIT:

THE TECHNICAL PART:

• Bachelor'sDegree in Engineering withfour (4) years of Process experience within the regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative and according to business needs.
• Experience in:
  • Drug Product Manufacturing
  • Characterization Processes
  • Process Performance Qualifications and Validations Lifecycle
  • Working knowledge of AI-enabled or automation tools such as Python, Codex, Power Automate, SQL, or VBA.

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• Develop engineering policies and procedures that affect multiple organizational units.
• Supervise, coordinate 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

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?