Manufacturing Engineer

EQVAL Group, Inc; Añasco (PR); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Life Insurance

PTO

Holidays

EQVAL Academy Certifications

Referral program

Productivity incentive

Job summary

EQVAL Group, Inc. in Puerto Rico seeks a Manufacturing Engineer with strong experience in medical device/pharmaceutical validation (IQ/OQ/PQ) and process optimization. The role focuses on validating equipment and processes, troubleshooting, and ensuring cGMP compliance in a fast-paced environment.

Candidate will design, optimize layouts, and collaborate across functions to support investigations (NCRs, Complaints) and CAPA. Must be fully bilingual (English/Spanish) and understand FDA/ISO audits.

Qualifications

• Bachelor’s degree in Engineering or related field and relevant validation experience.

Responsibilities

• Lead and execute validation activities for equipment and process changes (IQ/OQ/PQ).

Skills

IQ/OQ/PQ validation

Regulatory compliance

cGMP knowledge

Statistical analysis

Minitab

GR&R

DOE

MSA

CAPA

Lean Six Sigma

Bilingual EN/ES

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.