Manufacturing Engineer

EQVAL; Ponce (PR); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Competitive compensation

Career growth opportunities

Job summary

EQVAL Group, Inc. is seeking a Manufacturing Engineer with at least three years of experience in the Medical Device or Pharmaceutical industries. This full-time role is 100% on site in Ponce, Puerto Rico. Responsibilities include executing validation protocols and optimizing manufacturing processes.

Qualified candidates will have a Bachelor’s Degree in Engineering, experience in validation documentation, and be fully bilingual in English and Spanish. Competitive compensation and benefits are offered.

Qualifications

• 3+ years of experience in Medical Device or Pharmaceutical industries.
• Experience in validation protocols (IQ, OQ, PQ) and regulatory compliance.
• Good technical writing skills, fully bilingual in English and Spanish.

Responsibilities

• Develop and execute validation activities for equipment and process changes.
• Optimize manufacturing processes for efficiency and quality.
• Troubleshoot and improve production equipment and processes.
• Support investigations and implement corrective actions.

Skills

Validation documentation development

Lean Manufacturing

Six Sigma tools

Technical writing

pFMEA application

Bilingual (English and Spanish)

Education

Bachelor’s Degree in Engineering

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.

This opportunity will be full-time 100% on site in South, Puerto Rico.

Remote and hybrid work arrangements are not available for this positions.

We offer competitive compensation, benefits, and opportunities for career growth. If you are a motivated individual with passion and ready to represent EQVAL Group, we would love to hear from you. Apply now!!

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