Process Engineer - Validation & Automation (Pharma/Med Devices)

EQVAL; Arecibo (PR); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Health insurance

Life Insurance

Paid time off (PTO)

Holidays

Professional Growth (EQVAL Academy)

Referral program

Productivity incentive

Job summary

EQVAL Group, Inc. seeks Process Engineers to support development, validation, and implementation of new manufacturing processes in a regulated setting.

You will generate IQ/OQ/PQ documentation and Master Validation Plans, and help design in-process inspection systems for new components. Responsibilities include DOE, PFMEA, risk analysis, and cross-functional collaboration on technologies like laser welding, injection molding, and vision systems.

Qualifications

• Bachelor degree in engineering with electrical or mechanical backgrounds.
• 4+ years in regulated pharma, biotech or medical devices.
• Experience with automated manufacturing systems and equipment.
• Automation/controls, tooling, fixtures, test method development.
• Proficiency with DOE, FMEA, CAPA and root-cause investigation.
• Strong technical writing and bilingual English/Spanish.

Responsibilities

• Support development, validation, and implementation of new manufacturing processes.
• Generate documentation including IQ/OQ/PQ reports and Master Validation Plans.
• Design in-process and receiving inspection systems for new components.
• Characterize and optimize manufacturing processes using DOE, PFMEA and risk analysis.
• Collaborate cross-functionally with teams and technologies (laser welding, molding, vision).

Skills

Process validation

Equipment qualification

DOE

FMEA

CAPA

Root-cause investigation

Technical writing

Bilingual English/Spanish

Education

Bachelor Degree in Engineering

Tools

Automated manufacturing systems

Laser welding

Heat bonding

Injection molding

Vision systems

PLC/Servo/Pneumatics/Sensors

Job description

EQVAL Group, Inc. seeks Process Engineers to support development, validation, and implementation of new manufacturing processes in a regulated setting.

You will generate IQ/OQ/PQ documentation and Master Validation Plans, and help design in-process inspection systems for new components. Responsibilities include DOE, PFMEA, risk analysis, and cross-functional collaboration on technologies like laser welding, injection molding, and vision systems.