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Manufacturing Engineer – Process Development
Dorado, PR · Biotech/PharmaceuticalEngineer, Manufacturing Provides support to the Process Development team to efficiently facilitate operations within the production area, optimizing processes, and ensuring production goals are met. Monitors performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
Key Responsibilities:
•Support manufacturing basic daily activities and/or continuous improvement projects such as; equipment troubleshooting, root cause analysis and non-conforming product evaluation.
•Completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company. Prepares reports, publishes, and makes presentations to communicate findings.
•Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of problems which require novel and new innovative approaches.
•Cultivates internal and external network of resources to complete tasks. Participate in project teams to complete goals and objectives for the projects.
•Interacts cross functionally and with internal and external customers.
•Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products.
•Work with the Process Development team to efficiently qualify new processes; assist with statistical sampling plans, and other development procedures.
•Generate manufacturing instructions for new processes being developed.
Quality System Requirement:
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
•Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the Client Quality Policy.
•Establishes and promotes a work environment that supports the Quality Policy and Quality System.
**Weil Group is proud to be an Equal Employment Opportunity Employer.*
Key Responsibilities:
•Support manufacturing basic daily activities and/or continuous improvement projects such as; equipment troubleshooting, root cause analysis and non-conforming product evaluation.
•Completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company. Prepares reports, publishes, and makes presentations to communicate findings.
•Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of problems which require novel and new innovative approaches.
•Cultivates internal and external network of resources to complete tasks. Participate in project teams to complete goals and objectives for the projects.
•Interacts cross functionally and with internal and external customers.
•Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products.
•Work with the Process Development team to efficiently qualify new processes; assist with statistical sampling plans, and other development procedures.
•Generate manufacturing instructions for new processes being developed.
Quality System Requirement:
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
•Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the Client Quality Policy.
•Establishes and promotes a work environment that supports the Quality Policy and Quality System.
**Weil Group is proud to be an Equal Employment Opportunity Employer.*