Manufacturing Engineer

EQVAL Group, Inc; Juncos (PR); On-site; USD 75,000 - 110,000; 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. in Puerto Rico is seeking a Manufacturing Engineer to drive validation (IQ/OQ/PQ) and optimize manufacturing processes for Medical Device and Pharmaceutical environments.

This on-site role in Juncos requires strong cGMP knowledge and hands-on validation experience. Responsibilities include leading validation activities, designing efficient production layouts, and collaborating on investigations (NCRs/ CAPA) to improve quality and throughput.

Qualifications

• Bachelor’s degree in Engineering with Medical Device or Pharmaceutical exposure.
• Experience developing Validation Plans, URS, FRS, IQ, OQ, PQ and related reports.
• Hands-on FDA inspections, ISO audits, change control, non-conformance, CAPA.
• Strong cGMP knowledge for Medical Device manufacturing environments.
• Proficient in data analysis and GR&R; familiarity with Minitab.
• Bilingual English and Spanish communication skills.

Responsibilities

• Lead and execute validation activities for equipment and process changes, including IQ, OQ, PQ, and associated documentation.
• Design and 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 expertise

Process optimization

Troubleshooting

Statistical analysis (GR&R, MSA)

Lean Six Sigma

DOE (Design of Experiments)

Problem solving

Bilingual English/Spanish

Education

Bachelor’s degree in Engineering

Tools

Minitab

CAPA documentation

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.

The Manufacturing Engineer must have experience on Medical Device or Pharmaceutical industries, will focus on executing validation (IQ, OQ, PQ) and optimizing manufacturing processes. This role involves troubleshooting, improving production efficiency, and ensuring compliance with regulatory standards in a fast-paced environment.

Responsibilities

• Lead and execute validation activities for equipment and process changes, including IQ, OQ, PQ, and associated documentation.
• Design and 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 an Engineering field.
• Proven experience in developing and executing validation documentation, including Validation Plans, URS, FRS, IQ, OQ, PQ, and related reports.
• Hands-on experience in FDA inspections, ISO certifications, audits, and change control, non-conformance, and CAPA processes.
• Strong knowledge and experience in cGMP for Medical Device manufacturing environments.
• Proficiency in statistical analysis (GR&R) and data management, including tools like Minitab.
• Experience in areas such as investigations (NCRs, Complaints, CAPA), Lean Manufacturing, and Six Sigma tools.
• Experience with pFMEA (analysis and development) and its application.
• Expertise in Measurement System Analysis (MSA), including Attribute Analysis, GR&R, and Design of Experiments (DOE).
• Fully bilingual (English and Spanish) with exceptional communication skills, both spoken and written.
• 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 Juncos, 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.