Process Enineering Section Manager

08 Jun 2024

Vacancy expired!

Looking for a Process Engineering Section Manager to contribute to project technical teams, communicate and collaborate effectively to ensure effective interactions with all stakeholder groups. Manage a team of engineers to ensure proper design of technical/engineering studies and technical reports summarization of study results and data generation to support process development for new equipment, process changes, commodity changes and/or investigation/CAPA support. Complete change impact assessments for site changes as a technical SME. Generate/support/review/approve site technical assessments (alarm, risk, engineering). Support change management and implementation for changes to the manufacturing processes and associated systems. Support and lead technical team to identify potential process improvements projects. Manages implementation of process improvements projects and supports compliance driven projects that require technical support. Direct, mentor and train junior colleagues. Manage goal setting for direct reports, support achievement of identified goals against site goals, and completion of performance reviews. Support review, introduction and implementation of new technologies at the site. Identify and lead implementation of cost savings ideas, specifically efficiency improvements and other projects that increase equipment capacity. Develop and support qualification of manufacturing processes for drug products, taking into consideration problems inherent in Terminal Sterilization and Aseptic Filling processes and/or Packaging/Automated Visual Inspection (AVI) processes and technologies. Manage technical support in investigation of deviations that occur on the manufacturing floor. Lead root cause analysis and identifies appropriate, effective corrective actions. Implement corrective actions in conjunction with the appropriate enabling groups (engineering, maintenance, quality, validation, operations, EHS, etc.). Lead technical improvement projects aimed at defect reduction, improved equipment reliability, and better equipment utilization. Interface closely with site cross functional teams to specify user requirements and define project scopes. Collaborate with and influences other enabling departments (quality, engineering, maintenance, etc.) to assure initiatives are successful. Provide concise and thorough updates on initiatives to site leadership. Manage responsible work against site approved and/or capital project budget. Manage selection and onboarding of contract resources. Interface with auditors and presenting on site processes. Responsible for maintenance, review and approval of site documents to include calibration reports, batch records, SOPs, change control, design specs, etc. Ensure data integrity practices and procedures are implemented on all systems in Manufacturing for quality compliance and to meet industry standards. Support mapping of data flow for a system both electronic and paper handoffs. Review user access and system audit trails of manufacturing equipment and support/review data integrity investigations. Work with internal/external stake holders to improve data integrity by strengthening data capture, reporting and review processes. Provide support to Manufacturing and Quality to address data integrity issues identified during data review or audit.Skills needed- cGMP, Safety and Environmental Regulatory Requirements, Supervisory Experience, Drug Product Processing and Equipment (Big Plus), Manufacturing Experience (Big Plus)