Operational support of the biologics manufacturing process for commercial and clinical products. Responsible for ensuring ongoing operations via Engineering support, trouble shooting, root cause analysis, CAPA management and process optimization within multi-product, FDA regulated cGMP facilities.
This position will allow for fluid interaction between multiple departments, including Manufacturing, Facilities, Quality Assurance, Validation, Regulatory and site Engineering to facilitate closure of task items and completion of projects. May be involved in vendor management, equipment and facility design, including Conceptual Design, Basis of Design and Detailed Design, including equipment specification, procurement, construction, and commissioning of process equipment for cGMP production facilities. May be involved in technology transfers, including feasibility studies, facility fit assessment, generation of user requirements, process description, change control ownership, commissioning test plans, training of Site Engineers and Manufacturing personnel, as well as startup, commissioning, validation and operational support.
Direct Involvement Opportunities
- Troubleshooting of manufacturing support utilities and equipment, as well as evaluation of process anomalies.
- Serve as responsible engineer for cleaning (CIP/COP), sanitization/sterilization, process analytics, and bench-scale instruments.
- Implementation and assessment of single use technology.
- Serve as facilitator for correction and close out of action items in Quality Systems, such as TrackWise®.
Small Project Owner
- Manage small projects to ensure quality, cost and schedule.
- Accountable for all aspects of the Change Control process for implemented changes.
- Facilitate timely closure of equipment related CAPAs.
- Generation of supporting documentation (URSs, work orders, test protocols).
- Investigate and define all aspects of individual project scope.
- Provide Engineering review for Quality Engineering documentation.
Large Project Support
- Work with project team to generate engineering design requirements.
- Develop and support any feasibility studies or engineering tests required to define project scope.
- Coordinate with vendors to obtain proposals for equipment and support utility changes.
- Develop and execute engineering tests, FATs, SATs and commissioning test plans.
- Train Manufacturing personnel on new/revised operating procedures.
- Approve commissioning documentation and validation protocols.
- Troubleshoot and remediate deviations/exceptions found during Validation execution.
- BS or MS degree in Engineering
- 8+ Years relevant Industry experience