Manufacturing Engineer

EQVAL Group, Inc; Añasco (PR); Sur place; USD 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Health insurance (Medical, Dental, Vis

Life Insurance

Paid time off

Holidays

EQVAL Academy courses

Referral program

Productivity incentive

Résumé du poste

EQVAL Group, Inc. in Puerto Rico is seeking a Manufacturing Engineer with medical device/pharma experience to lead validation activities (IQ, OQ, PQ) and optimize production processes.

The role focuses on troubleshooting, building robust validation documentation, supporting regulatory audits (FDA ISO), and driving continuous improvement with Lean and Six Sigma tools.

This on-site position in Juncos offers full-time work with benefits and opportunities for growth through EQVAL Academy.

Qualifications

• Bachelor's degree in engineering or related field.
• Experience developing and executing validation documentation (Validation Plans, URS, FRS, IQ/OQ/PQ).
• Hands-on FDA inspections, ISO audits, change control, CAPA and non-conformance handling.
• Strong cGMP knowledge for medical device manufacturing.
• Proficiency in GR&R and data management using Minitab.
• Experience with NCRs/Complaints, Lean, Six Sigma, pFMEA, MSA, and DOE.
• Fully bilingual English/Spanish with strong communication skills.

Responsabilités

• Lead validation activities for equipment and process changes (IQ/OQ/PQ) and document results.
• Design and optimize manufacturing processes, layouts, and material handling.
• Troubleshoot equipment/process issues to improve efficiency and quality.
• Collaborate on investigations and implement corrective actions (NCRs, CAPA, complaints).
• Ensure regulatory compliance (cGMP) across manufacturing and validation activities.

Connaissances

GR&R

DOE

Six Sigma

Lean Manufacturing

MSA

Statistical analysis

Bilingual English/Spanish

Formation

Bachelor's degree in Engineering

Outils

Minitab

Description du poste

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.

Minimum Requirements:

• 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.

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 Juncos, Puerto Rico.

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