Senior Manufacturing Engineer

EQVAL Group, Inc; Humacao (PR); Sur place; USD 65 000 - 95 000; Plein temps

Avantages offerts par ce poste

Life Insurance

Paid time off

Holidays

Professional Growth (EQVAL Academy)

Referral program

Productivity incentive

Résumé du poste

EQVAL Group, Inc. is seeking a Manufacturing Engineer with strong experience in validation (IQ/OQ/PQ) and process optimization within Medical Device or Pharmaceutical environments.

The role focuses on executing validation, improving production efficiency, and ensuring regulatory compliance in a fast-paced setting. The ideal candidate will lead validation activities, design efficient manufacturing processes, troubleshoot issues, and collaborate across functions to support CAPA, NCRs, and

Qualifications

• Bachelor’s degree in Engineering required.
• Experience developing and executing validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ, and reports).
• Experience with FDA inspections, ISO audits, change control, non-conformance, and CAPA processes.
• Strong knowledge of cGMP for Medical Device manufacturing.
• Proficiency in statistical analysis and data management (GR&R, MSA) using tools like Minitab.

Responsabilités

• Lead and execute validation activities for equipment and process changes (IQ/OQ/PQ) and related documentation.
• Design and optimize manufacturing processes and layouts for efficient production.
• Troubleshoot equipment and processes to improve efficiency and product quality.
• Collaborate with cross-functional teams to support investigations and corrective actions.
• Ensure regulatory compliance (cGMP) across manufacturing and validation activities.

Connaissances

Validation execution

IQ/OQ/PQ

cGMP compliance

Lean manufacturing

Six Sigma

CAPA investigations

NCRs/Complaints handling

Familiar with FDA inspections

MSA/GR&R/DOE

Data analysis (Minitab)

Cross-functional collaboration

Bilingual English/Spanish

Formation

Bachelor’s degree in Engineering

Outils

Minitab

DOE

GR&R

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.
• 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.