Manufacturing Engineer

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

Benefits offered by this job

Life Insurance

PTO

Holidays

EQVAL Academy Courses

Referral program

Productivity incentive

Job summary

EQVAL Group, Inc. seeks a Manufacturing Engineer experienced in Medical Device/Pharma validation to join our on-site team in Juncos, Puerto Rico. You will lead IQ/OQ/PQ validation activities, optimize manufacturing processes and ensure regulatory compliance.

The role requires hands-on validation documentation, experience with FDA inspections and CAPA workflows, and strong MSA/DOE skills. Bilingual in English and Spanish is a plus; compensation includes benefits and growth opportunities.

Qualifications

• Bachelor's degree in Engineering required.
• Experience in Medical Device or Pharmaceutical validation.
• Hands-on experience with FDA inspections, ISO audits, change control, CAPA.

Responsibilities

• Lead and execute validation activities for equipment and processes (IQ, OQ, PQ) and related docs.
• Design and optimize manufacturing processes, layouts, material handling and tooling.
• Troubleshoot and improve production equipment to enhance efficiency and quality.
• Collaborate with cross-functional teams to investigate NCRs, complaints and implement corrective actions.
• Ensure compliance with cGMP in all processes and validation activities.

Skills

Validation IQ/OQ/PQ

GxP & cGMP

Statistical analysis

DOE

MSA

Lean Six Sigma

NCRs/CAPA

Education

Bachelor's degree in Engineering

Tools

Minitab

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.