About this role
- Participates in and supports the design, implementation, and optimization of manufacturing processing including but not limited to:
- 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.
- Ability to prepare/issue change controls, CAPAs, and investigations.
- Participates in and supports validation projects within the cGMP regulated manufacturing areas, including but not limited to:
Prepare, review, and execute commissioning, qualification and validation documents for equipment and computerized systems/software.
- Supporting Project teams in: User Requirement Specifications, GMP Impact Assessments, Traceability Matrices, Design Qualifications, and Risk Assessments.
- 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.
Salary range: $75,000 - $90,000 annually