Job Overview:
Biopharmaceutical Process Equipment Engineer
This position is responsible for the design and specification of new and renovated biopharmaceutical process equipment.
Key Responsibilities:
* Designing and specifying cGMP process equipment, piping, and controls to meet regulatory requirements
* Leading small-to-mid-sized projects related to process equipment and manufacturing to ensure timely completion and within budget
* Providing engineering support and problem-solving for existing equipment and manufacturing processes
* Developing Process Flow Diagrams for manufacturing processes and preparing piping and instrumentation diagrams and other related drawings
* Collaborating with the QA Validation department to prepare design documents and assist in protocol execution
* Investigating process equipment, utility systems, and control system anomalies, as well as safety incidents, and implementing corrective/preventative actions
* Preparing engineering evaluations and test plans for change control documentation
* Supervising mechanical, electrical, and automation contractors to ensure compliance with company policies and regulations
Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations. Ensuring compliance with all relevant laws, policies, and regulations to maintain company reputation.
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