Manufacturing Engineer

EQVAL Group, Inc; Ponce (PR); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Life Insurance

Paid time off

Holidays

Growth opportunities

Referral program

Productivity incentive

Job summary

EQVAL Group, Inc. in Dorado, Puerto Rico, seeks Manufacturing Engineers with 3+ years in Medical Device or Pharmaceutical environments. The role centers on executing IQ/OQ/PQ validation, troubleshooting, and optimizing manufacturing processes on-site.

Ideal candidates hold a Bachelor’s in Engineering, have experience with validation docs and NCR/CAPA investigations, and are fluent in English and Spanish. Growth opportunities and competitive benefits are offered.

Qualifications

• Bachelor’s Degree in Engineering.
• Experience in validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ).
• Experience with NCRs, Complaints, CAPA, Lean Manufacturing, and Six Sigma tools.
• Experience with pFMEA and its application.
• Fully bilingual English and Spanish.
• Good technical writing skills.

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.

Skills

Validation documentation

NCR/ CAPA investigations

Lean Manufacturing

Six Sigma tools

Bilingual English/Spanish

Technical writing

Education

Bachelor’s Degree in Engineering

Tools

pFMEA

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

Minimum Requirements

• 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

Benefits

• Health insurance (Medical, Dental, Vision, Pharmacy)
• 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.