Associate Manufacturing Engineer
About The Position
This role participates in and supports the design, implementation, and optimization of manufacturing processes. Key responsibilities include developing and maintaining Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and work instructions. The position involves monitoring and analyzing production data to identify trends and opportunities for improvement, aiming to enhance efficiency, safety, and compliance for both existing and new processes. The role also includes participation in continuous improvement initiatives like lean manufacturing and Six Sigma, as well as validation and implementation of manufacturing equipment and computer systems/software. A significant part of the role involves conducting risk assessments on process steps, improving manufacturing efficiency through workflow analysis, and identifying and resolving technical issues impacting performance. Technical support for troubleshooting equipment and process deviations, and assisting in training production personnel are also key functions. The role requires the ability to prepare and issue change controls, CAPAs, and investigations. Additionally, the position supports validation projects within cGMP regulated manufacturing areas, including preparing, reviewing, and executing commissioning, qualification, and validation documents. This involves supporting project teams with User Requirement Specifications, GMP Impact Assessments, Traceability Matrices, Design Qualifications, and Risk Assessments. The role requires handling multiple commissioning, qualification, and validation priorities with management guidance, assisting in troubleshooting equipment/computer system issues, process characterization, and root cause investigations. Involvement in resolving deviations/non-conformances during validation activities and applying FMEA processes are also expected.
Requirements
- Ability to prepare/issue change controls, CAPAs, and investigations.
- Ability to handle multiple commissioning, qualification, and validation priorities based on the needs of the manufacturing area and project team with guidance from management.
- Assisting in troubleshooting of equipment/computer system issues, process characterization and root cause investigations.
- Involved in resolving deviations/non-conformances observed during execution of qualification and validation activities.
- Apply FMEA process to evaluate failure data, if necessary, from field data to find root cause and implement sound engineering solutions.
Responsibilities
- Develop and maintain Standard Operating Procedures (SOPs), Master Batch Records (MBRs), and work instructions.
- Monitor and analyze production data to identify trends and opportunities for improvement.
- Improve efficiency, safety, and compliance, including existing and new processes.
- Participate in continuous improvement initiatives such as lean manufacturing and Six Sigma methodologies.
- Validation and implementation of manufacturing equipment and computer system/software validations.
- Conduct risk assessment on process steps and their ability to meet requirements.
- Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
- Identify and resolve technical issues impacting manufacturing performance.
- Provide technical support for troubleshooting equipment and process-related deviations.
- Assist in training production personnel on new equipment and processes.
- Prepare/issue change controls, CAPAs, and investigations.
- Prepare, review, and execute commissioning, qualification and validation documents for equipment and computerized systems/software.
- Support Project teams in: User Requirement Specifications, GMP Impact Assessments, Traceability Matrices, Design Qualifications, and Risk Assessments.
- Handle multiple commissioning, qualification, and validation priorities based on the needs of the manufacturing area and project team with guidance from management.
- Assist in troubleshooting of equipment/computer system issues, process characterization and root cause investigations.
- Resolve deviations/non-conformances observed during execution of qualification and validation activities.
- Apply FMEA process to evaluate failure data, if necessary, from field data to find root cause and implement sound engineering solutions.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
