Senior Bioprocessing Engineering Specialist
Design, develop and implement scalable biopharmaceutical process equipment solutions, provide technical expertise and manage projects.
* Project Management: Oversee project scope, deliverables, scheduling, budgeting and quality of cGMP process equipment, piping, controls and facility.
* Assist in design review, site acceptance and installation of equipment.
* Prepare and present project status reports to stakeholders.
* Present and disseminate technical information relating to equipment, engineering and GMPs.
* Recommend and manage implementations of corrective actions for existing equipment and manufacturing processes.
* Develop and maintain departmental policies, procedures and specifications.
* Act as Subject Matter Expert during regulatory inspections and internal investigations.
* Support QA Validation by preparing design documents and assisting with protocol execution.
* Analyze and investigate process equipment, utility systems and control system anomalies, as well as safety incidents.
* Prepare engineering evaluations and test plans for change control documentation.
* Lead mechanical, electrical and automation contractors on-site.
* Maintain a safe working environment by enforcing procedures, policies and regulations.