EQVAL Group, Inc. is a company that provides services to the manufacturing industry ( Medical Devices, Pharmaceuticals, Biotechnologies, others ).
We work with an extraordinary group of professionals ( employees and contractors ) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.
The Manufacturing Engineer supports New Product Introductions (NPI) and process transfers in a regulated environment.
Key responsibilities include generating and executing validation protocols, setting up and troubleshooting equipment, and driving continuous improvement.
Additionally, the role involves supporting investigations (NCRs, Complaints) and collaborating with Manufacturing and QA teams for timely resolution.
Minimum Requirements: Bachelor's Degree in Engineering or a related field.
2+ years of experience in cGMP within a Medical Devices manufacturing environment is preferrable. Experience with equipment commissioning, qualification, and process validation (including IQ, OQ, PQ protocols).
Proven expertise in change control of Medical Devices, including equipment and process changes.
Strong background in statistical analysis (e.g., GR&R) and data management, with proficiency in statistical tools such as Minitab.
Experience with preventive maintenance strategy development and implementation.
Proficiency in equipment and process performance metrics analysis (e.g., Yield, Downtime, OEE).
Demonstrated experience in Computer System Validation (CSV) and Quality/Process Control/Assurance of Medical Devices.
Ability to troubleshoot technical issues and provide effective solutions.
Strong communication, problem-solving, and relationship-building skills.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Minitab.
Fluent in English and Spanish, with excellent written and verbal communication skills.
Preferred Qualifications: Experience with manufacturing, packaging, and laboratory equipment.
Knowledge of Lean Manufacturing and Six Sigma methodologies.
Key Responsibilities: Generate and execute validation protocols for new or modified equipment and processes.
Take ownership of equipment and process changes, ensuring accurate and effective process instructions that comply with applicable regulations.
Define and implement equipment maintenance strategies to optimize cost, compliance, and effectiveness.
Work with other functions to align maintenance strategies with current operations and ensure best practices are followed.
Revise and manage spare parts lists for equipment.
Develop and implement preventive maintenance strategies and instructions.
Monitor and analyze equipment and process performance metrics (e.g., Yield, Downtime, OEE) to drive improvements.
Assess and manage change control requirements for equipment and processes.
Review and revise Standard Operating Procedures (SOPs) related to processes and equipment.
Only local candidates will be considered .
Job Types: Full-time, Contract Benefits: Dental insurance Employee assistance program Employee discount Health insurance Life insurance Paid time off Professional development assistance Referral program Powered by JazzHR
