Manufacturing Engineer
Juncos, Juncos, Puerto Rico
Contracted to Full Time
Mid Level
EQVAL Group, Inc. is a company that provides technical and engineering services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies) and other service companies. We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, to perform and provide a highly effective service.
The Manufacturing Engineer will support manufacturing and validation activities within a regulated medical device environment. This role is responsible for executing process validations, supporting equipment qualifications, managing risk documentation, and ensuring compliance with quality and regulatory standards while providing technical leadership and cross-functional collaboration.
Requirements:
The Manufacturing Engineer will support manufacturing and validation activities within a regulated medical device environment. This role is responsible for executing process validations, supporting equipment qualifications, managing risk documentation, and ensuring compliance with quality and regulatory standards while providing technical leadership and cross-functional collaboration.
Requirements:
- 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.*
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