Key skills
Validation PlansUser Requirements Specification (URS)Functional Requirements Specification (FRS)Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Non-Conformance Reports (NCRs)Corrective and Preventive Actions (CAPA)Lean ManufacturingSix SigmaProcess Failure Mode and Effects Analysis (pFMEA)Bilingual English and Spanish
About this role
EQVAL Group, Inc. is a company that provides services to the manufacturing industry, and they are seeking Process Engineers with at least three years of experience in Medical Device or Pharmaceutical industries. The role will focus on executing validation protocols, troubleshooting, and optimizing manufacturing processes.
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
Requirements:
- 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