
Senior Equipment Specialist
6 days ago
This role involves designing, specifying and commissioning new and renovated biopharmaceutical process equipment.
Main Responsibilities:- Design and Specification: Designing and specifying cGMP process equipment, piping, and controls
- Project Management: Managing small-to-mid-sized projects related to process equipment and manufacturing
- Site Acceptance and Installation: Assisting in the design review, site acceptance and installation of equipment
- Drawing Development: Preparing piping and instrumentation diagrams and other related drawings
- Process Flow Diagrams: Developing Process Flow Diagrams for manufacturing processes
- Support QA Validation: Supporting QA Validation department by preparation of design documents and assists in protocol execution
- Anomaly Investigation: Assisting in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents
- CORRECTIVE ACTIONS: Implementing corrective/preventative actions for existing equipment and manufacturing processes
- Engineering Evaluations: Preparing engineering evaluations and test plans for change control documentation
- Education: BS/BEng in Chemical, Process or Mechanical engineering with 8+ years related experience
- Experience: Direct experience with biopharmaceutical process equipment is preferred
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