Manufacturing Engineer

• Bachelor’s Degree in Engineering 

• Minimum 2 years of experience in a Medical Device, Pharmaceutical, or Biotechnology regulated manufacturing environment.

• Experience with process validation (PV) and equipment qualification activities.
• Knowledge of Computer System Validation (CSV) and IT systems in regulated environments.
• Experience managing documentation changes.
• Experience with risk management documentation (pFMEAs).
• Basic knowledge of statistics (preferably using Minitab).
• Experience supporting design transfer activities (preferred).
• Knowledge of medical device regulations (preferred).
• Demonstrated technical leadership capabilities.

• Generate and execute process validation plans and reports (PV: Characterization, OQ, PQ — excluding cleaning validation).
• Support equipment qualification activities (URS, FAT, IQ, OQ, PQ, TMV — non-laboratory equipment).
• Define and support validation strategies, ensuring requirements flow-down from design to manufacturing.
• Develop and maintain risk management documentation, including pFMEAs.
• Manage and implement documentation changes in compliance with regulated environment standards.
• Support design requirements validation and manufacturing control implementation (non-Operational Excellence focus).
• Provide technical leadership and guidance to cross-functional teams.
• Ensure compliance with applicable medical device regulatory requirements.

• Paid time off
• Health insurance
• Dental insurance
• Vision insurance
• Life insurance
• Employee assistance program
• Employee discount
• Professional development (certifications, courses & assistance)
• Referral program

*Please note that this is a long-term position and requires 100% on-site presence in Juncos, Puerto Rico.*