• 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