Engineer
Posted on :
11-06-2022
Employer Active
1 Vacancy
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Jobs by Experience
2 years
Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
11-06-2022
Job Description
Req ID : 1137746
Engineer with experience in manufacturing of bio-processes to bring operations support and applicable execution of manufacturing/quality systems such as design of operations and system requirements, procedures, deviation investigations, process monitoring, training, and new product introductions. Organizes, analyzes and presents interpretation of results for operational issues or projects.
Responsibilities:
- Routinely monitor manufacturing processes.
- Suggest problem resolution and provide troubleshooting guidance.
- Assess observations from floor operations and gather and analyze data to identify root cause and implement solutions for process improvement opportunities.
- Function as a technical expert to process or systems regarding troubleshooting operations.
- Participate in the New Product Introductions (NPI) NPI to assess requirements for documentation, materials, training, and equipment modifications.Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
- Initiate, revise, and approve manufacturing controlled documents in the Document Management System .
- Ensure all manufacturing controlled documents reflect current operations. Serve as a document author, owner, reviewer, or data verified, as needed.
- Perform deviations assessments and support deviation lead during the root cause, human performance evaluation, CAPA development, and closure of record within established goal.
- Monitor effectiveness of CAPA implemented to prevent recurrence of deviation.
Requirements
- Master s or Bachelor s degree in Engineer and 2 years of engineering experience
- Bilingual (Spanish/English)
- Skilled in performance of GMP production operations
- Regulatory knowledge and interactions
- Organizational, technical writing and presentation skills.
- Project management skills
- Knowledge of control charting and basic statistics
Master s or Bachelor s degree in Engineer and 2 years of engineering experience Bilingual (Spanish/English) Skilled in performance of GMP production operations Regulatory knowledge and interactions Organizational, technical writing and presentation skills. Project management skills Knowledge of control charting and basic statistics
Employment Type
Full Time
Key Skills
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