We are seeking a Senior Project Engineer who will be responsible for designing, specifying and commissioning new and renovated biopharmaceutical process equipment. This position will provide engineering support and problem solving support for existing equipment and manufacturing processes.
As a Sr Project Engineer, a typical day might include the following:
Designing and specifying cGMP process equipment, piping, and controls
Managing small-to-mid-sized projects related to process equipment and manufacturing
Assisting in the design review, site acceptance, and installation of equipment
Preparing piping and instrumentation diagrams (P&IDs) and other related drawings
Developing Process Flow Diagrams (PFDs) for manufacturing processes
Supporting the QA Validation department by preparing design documents and assisting in protocol execution
Reviewing and approving lifecycle documentation, cleaning validation protocols, and summary reports
Assisting with investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents
Assisting management with tracking of department throughput and efficiency
Representing the engineering department at cross-functional meetings
Supervising direct reports as needed
Implementing corrective/preventative actions for existing equipment and manufacturing processes
Preparing engineering evaluations and test plans, and executing change control documentation
Supervising mechanical, electrical, and automation contractors as needed
Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations
Maintaining company reputation by ensuring compliance with all relevant laws, policies, and regulations
This role may be for you if:
You have excellent technical and analytical skills.
You are skilled at problem-solving and continuous improvement.
You possess strong communication and collaboration skills.
You are adaptable and can work in a fast-paced, regulated environment
To be considered for this opportunity you should have a
BS/BEng or higher in
chemical/process/mechanical
engineering with 5+ years of related experience. Direct experience with biopharmaceutical process equipment is preferred. May substitute relevant experience for education.