- Reference: GY43497
- Job Type: Permanent
- Location: Clare, Limerick, Limerick City
- Category: Engineering, Technical & Manufacturing
The Project Engineer will design, specify and commission new and renovated biopharmaceutical process equipment. They will provide engineering support and problem solving for existing equipment and manufacturing processes.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Designs and specifies cGMP process equipment, piping, and controls.
• Manages small-to-mid sized projects related to process equipment and manufacturing.
• Assists in the design review, site acceptance and installation of equipment.
• Prepares piping and instrumentation diagrams and other related drawings.
• Develops Process Flow Diagrams for manufacturing processes.
• Supports QA Validation department by preparation of design documents and assists in protocol execution.
• Assists in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
• Implements corrective/preventative actions for existing equipment and manufacturing processes.
• Prepares engineering evaluations and test plans for and executes change control documentation.
• May supervise mechanical, electrical, and automation contractors.
• Maintains a clean and safe working environment by enforcing procedures, policies, and regulations.
• Maintains company reputation by enforcing compliance with local, state, and federal regulations.
Knowledge and Skills:
• Working knowledge of cGMPs and sanitary equipment design requirements.
• Working knowledge of process control systems and automation.
• Advanced knowledge of engineering documentation required for cGMP process equipment.
• Substantial knowledge of clean room design & function and biopharmaceutical equipment.
• Strong written and oral communication skills.
• Ability to understand project plans and schedules.
• Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
Education and experience:
• Requires BS/BA or higher in chemical or biochemical engineering
• 2-5 years of related experience
• Direct experience with biopharmaceutical process equipment is preferred.
• May substitute relevant experience for education.