Manufacturing Engineer

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:

• Bachelors 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.

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. Apply now!!

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