Manufacturing Engineer
On-sitePonce, Ponce, Puerto Rico
Job Summary
Develop and execute validation activities for equipment and process changes, including IQ, OQ, and PQ protocols, while ensuring full compliance with cGMP regulatory standards. Optimize manufacturing processes to improve production layouts, material handling, and tool fabrication, and troubleshoot production equipment to enhance operational efficiency and product quality. Collaborate with cross-functional teams to support investigations into NCRs and complaints, implementing corrective actions and applying Lean Manufacturing and Six Sigma tools. This full-time on-site role in Dorado, Puerto Rico requires a bilingual engineer with three years of experience in Medical Device or Pharmaceutical industries to lead validation documentation and process optimization efforts.
Required Qualifications
- 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
- This position will be full-time 100% on site in Dorado, Puerto Rico
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