Process Improvement Specialist (contractor)
About The Position
Main Responsibilities: Lead process problem solving and ensures that root causes, corrective and preventive actions are identified and implemented to prevent recurrence. Document problem solving and technical assessment for deviations within the target closure time. Accountable for the evaluation of deviation trends and recommend actions to achieve continuous improvement to meet Operations and Site goals. Responsible for manufacturing/or packaging process investigations. Responsible for the identification and implementation of scientific and technological opportunities in manufacturing and/or packaging areas for cost, cycle time and quality improvements. Analyzes data, recommends, designs and implements process performance improvements. Responsible for continuous process verification activities within the department for in line products (i.e. Risk Assessments, Process Specific Trainings). Proactive Process Analysis owner for Operations. Executes change requests and qualifications for existing equipment. Provides technical support for the validation of new and existing processes, cleaning assessments and experimental trials. Provides technical support on new product introduction and product transfer activities, including data gathering and analysis, sampling and validation. Accountable in the development of technical training and SOPs. Responsible to support Process Change Request process, including performing activities as required by regulatory documentation such as PCR, ECR, among others.
Requirements
- Bachelor´s degree in Science, Engineering or Business Administration
- 5+ years of direct related experience in technical investigations, process optimization, continuous improvement, validation support, and regulatory documentation
- Communicates clearly and concisely in English / Spanish orally and written.
- Knowledge of Regulations such as cGMP’s and EMEA.
Responsibilities
- Lead process problem solving and ensures that root causes, corrective and preventive actions are identified and implemented to prevent recurrence.
- Document problem solving and technical assessment for deviations within the target closure time.
- Accountable for the evaluation of deviation trends and recommend actions to achieve continuous improvement to meet Operations and Site goals.
- Responsible for manufacturing/or packaging process investigations.
- Responsible for the identification and implementation of scientific and technological opportunities in manufacturing and/or packaging areas for cost, cycle time and quality improvements.
- Analyzes data, recommends, designs and implements process performance improvements.
- Responsible for continuous process verification activities within the department for in line products (i.e. Risk Assessments, Process Specific Trainings).
- Proactive Process Analysis owner for Operations.
- Executes change requests and qualifications for existing equipment.
- Provides technical support for the validation of new and existing processes, cleaning assessments and experimental trials.
- Provides technical support on new product introduction and product transfer activities, including data gathering and analysis, sampling and validation.
- Accountable in the development of technical training and SOPs.
- Responsible to support Process Change Request process, including performing activities as required by regulatory documentation such as PCR, ECR, among others.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
