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Provide guidance and support for Excel data migration and process Failure Mode and Effect Analysis in a manufacturing environment. Evaluate and enhance process FMEA documents and ensure compliance with industry guidelines.
Complete complex assignments, develop engineering policies and procedures, supervise staff, apply advanced engineering techniques, and serve as a specialist in engineering technology. Bilingual in English and Spanish required.
Sr. Engineer role in a Service Provider company focusing on Engineering and Packaging services within the pharmaceutical and medical device industry. Responsibilities include developing engineering policies, supervising staff, applying advanced engineering techniques, serving as a technology specialist, and planning and conducting projects.
Executing functional deliverables associated with Process Development and Technology Development projects, assessing process capabilities, implementing process improvements, supporting testing, organizing testing data, proposing solutions to technical challenges, and collaborating with cross-functional teams.
Support process and equipment validation activities, develop validation plans, review and develop process validation protocols, design quality systems, generate equipment documentation, define test methods, and work cross-functionally with other departments.
The Engineering Technician will be responsible for design services in the engineering area, including 2D/3D drawing interpretation, AutoCAD expertise, and knowledge in Safety/EHS regulations. The role involves analytical problem-solving, effective communication, and collaboration with peers. The company is a service provider focused on integrating various technical services for clients in the pharmaceutical, medical device, and manufacturing industries.
Create, monitor, and analyze project schedules in accordance with best project practices. Co-ordinate project schedules, tasks, and meeting updates. Support Project Manager with Project Change Management activities. Develop and implement applicable communication strategy and metrics.
Design and plan layout for various manufacturing activities, adapt machine designs, inspect machinery performance, comply with quality standards, leverage engineering expertise
Responsible for compliance with corporate and divisional policies, identifying manufacturing process defects, performing line situation triage, owning exception/CAPA activities, evaluating lot to lot yield, and reporting quality metrics. Develops product quality plans, documents, and systems by providing input to product specifications and quality plans. Collaborates with process owners and supports engineering studies and validations.
Specialist QA responsible for reviewing and approving product MPs, leading investigations, approving change controls, and providing lot disposition. Must have a Bachelor's Degree and 5 years of experience in the regulated industry.
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