Manufacturing Engineer

EQVAL Group, Inc; Ponce (PR); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Life Insurance

Paid time off (PTO)

Holidays

Professional Growth (EQVAL Academy)

Referral program

Productivity incentive

Job summary

EQVAL Group, Inc. is seeking Manufacturing Engineers with 3+ years of experience in Medical Device or Pharmaceutical industries to execute validation protocols (IQ, OQ, PQ) and optimize manufacturing processes.

The role requires troubleshooting, cross‑functional collaboration, and adherence to cGMP standards. The position is on-site in Dorado, Puerto Rico, with growth opportunities and comprehensive benefits.

Qualifications

• Bachelor’s degree in Engineering required.
• 3+ years in Medical Device or Pharmaceutical industries.
• Experience validating equipment/process changes (IQ/OQ/PQ).
• Experience with NCRs, Complaints, CAPA, Lean, and Six Sigma tools.

Responsibilities

• Develop and execute validation activities for equipment and process changes (IQ, OQ, PQ) and related documentation.
• Optimize manufacturing processes, ensure efficient production layouts and material handling.
• Troubleshoot and improve production equipment and processes for quality and efficiency.
• Collaborate with cross‑functional teams to support investigations and corrective actions.
• Ensure compliance with regulatory standards (cGMP) in manufacturing and validation.

Skills

IQ/OQ/PQ Validation

Process Optimization

Troubleshooting

Regulatory Compliance

Cross-functional Collaboration

Lean Manufacturing

Six Sigma

pFMEA

Bilingual English/Spanish

Education

Bachelor’s Degree in Engineering

Tools

URS/FRS Documentation

Validation Plans

Job description

EQVAL Group, Inc. is a company that provides services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies, others). We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.

We are seeking Manufacturing Engineers with at least three (3) years of experience in Medical Device or Pharmaceutical industries. The role will focus on executing validation protocols (IQ, OQ, PQ), troubleshooting, and optimizing manufacturing processes.

Responsibilities:

• Develop and execute validation activities for equipment and process changes (IQ, OQ, PQ) and associated documentation
• Optimize manufacturing processes, ensuring efficient production layouts, material handling, and tool fabrication
• Troubleshoot and improve production equipment and processes to enhance operational efficiency and product quality
• Collaborate with cross-functional teams to support investigations (NCRs, Complaints) and implement corrective actions
• Ensure compliance with regulatory standards (cGMP) in all manufacturing processes and validation activities
• Bachelor’s Degree in Engineering
• Experience in developing and executing validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ)
• Experience in investigations (NCRs, Complaints, CAPA), Lean Manufacturing, and Six Sigma tools
• Experience with pFMEA (analysis and development) and its application
• Fully bilingual (English and Spanish) spoken and written
• Good technical writing skills
• Life Insurance
• Paid time off (PTO)
• Holidays
• Professional Growth (Courses and Certifications by EQVAL Academy)
• Referral program
• Productivity incentive

*This position will be full-time 100% on site in Dorado, Puerto Rico.

We offer competitive compensation, benefits, and opportunities for career growth. If you are a motivated individual with passion, we would love to hear from you.

EQVAL Group is an EEO. We comply with all federal, local, and state laws regarding non-discrimination.