Manufacturing Engineer II: Process Design & Compliance

FITS, LLC; Juncos (PR); On-site; USD 75,000 - 95,000; Full time

Job summary

FITS, LLC located in Juncos, Puerto Rico, is in search of an experienced Engineer. You'll be responsible for complex engineering tasks and supervision of staff while ensuring compliance and optimization within packaging processes.

Your engineering expertise will lead project management efforts, developing essential policies and budgets for multiple projects. The role demands significant industry experience and a Bachelor's degree in Engineering.

Qualifications

• Bachelor's Degree in Engineering with four years of Packaging Process experience within the regulated industry.
• Experience in C&Q strategy, planning, execution, and GMP systems.
• Ability to supervise and coordinate small teams of engineers and technicians.

Responsibilities

• Complete complex assignments requiring new engineering techniques.
• Develop engineering policies affecting multiple organizational units.
• Supervise and review work of engineers and technicians.
• Coordinate work with consultants and architects.
• Develop and manage departmental or project budgets.

Skills

C&Q strategy, planning, and execution (IQ/OQ/PQ, CSV)

Packaging process design, optimization, and compliance

GMP systems: HVAC, process equipment, and utilities

DeltaV, PLC, and SCADA control systems

Biologics, drug substance, and drug product environments

Education

Bachelor's Degree in Engineering

Job description

FITS, LLC located in Juncos, Puerto Rico, is in search of an experienced Engineer. You'll be responsible for complex engineering tasks and supervision of staff while ensuring compliance and optimization within packaging processes.

Your engineering expertise will lead project management efforts, developing essential policies and budgets for multiple projects. The role demands significant industry experience and a Bachelor's degree in Engineering.