Manufacturing Engineer

Summary

EQVAL Group, Inc. provides services to the manufacturing industry, including medical devices, pharmaceuticals, and biotechnology. The Manufacturing Engineer will execute equipment and process validation protocols, troubleshoot and optimize manufacturing processes, support investigations and corrective actions, and ensure cGMP compliance.

Responsibilities

• Develop and execute validation activities for equipment and process changes (IQ, OQ, PQ) and associated documentation
• 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

Skills

• At least three (3) years of experience in Medical Device or Pharmaceutical industries
• Bachelor's Degree in Engineering
• Experience in developing and executing validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ)
• Experience in investigations (NCRs, Complaints, CAPA), Lean Manufacturing, and Six Sigma tools
• Experience with pFMEA (analysis and development) and its application
• Fully bilingual (English and Spanish) spoken and written
• Good technical writing skills

Qualifications

Must Haves

• at least three (3) years of experience in Medical Device or Pharmaceutical industries
• Bachelor's Degree in Engineering
• Experience in developing and executing validation documentation (Validation Plans, URS, FRS, IQ, OQ, PQ)
• Experience in investigations (NCRs, Complaints, CAPA), Lean Manufacturing, and Six Sigma tools
• Experience with pFMEA (analysis and development) and its application
• Fully bilingual (English and Spanish) spoken and written
• Good technical writing skills

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