This role is for Process Engineer to support the process engineering work of upstream and downstream bioprocess systems/equipment and single-use technology equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries.
Responsibilities:
- Support in performing/reviewing process engineering drawings and calculations, as part of engineering design or as part of verification of calculations of vendors/client/other consultants. Calculations may include heat exchanger, pump, piping, control valve sizing, heat and mass balances, as well as other engineered calculations
- Support in preparing/reviewing technical data sheets for various equipment, instrumentation, and systems.
- Support in preparing/reviewing risk assessments and HAZOPs.
- Support in preparing/reviewing automation sequences, as required for Process Automation.
- Coordination with other engineering disciplines and other cross-functional departments (automation engineering, facilities engineering, process engineering, validation, project management, operations, quality, safety).
- Commissioning project Plan, Validation Project Plan, Design Qualifications, Traceability Matrixes,
- Commissioning protocols, Qualification protocols, Validation protocols for pharmaceutical equipment and systems.
- Ensure the client’s process equipment and facilities are operating as intended to meet the requirements for biopharmaceutical manufacturing.
- Provides the client the tactical support of ongoing plant operations and strategic implementation of engineering projects to meet the changing needs of the business.
- Act as the client’s system technical owner for upstream, downstream equipment and other unit operations.
- Assist the client’s validation department with execution of qualification protocols.
- Author standard operating procedures (SOPs) for process equipment maintenance and preventive maintenance (PM) checklists.
- Review vendor turnover package documentation to ensure it meets all requirements.
- Identify and assist in procurement of spare parts required for process equipment maintenance activities.
- Manage construction activities associated with implementation of engineering projects.
- Own and implement projects to address Corrective Actions / Preventative Actions (CAPA) identified as part of deviation investigations, request from value stream stakeholders or GMP audits.
- Provide on the floor troubleshooting support for the client’s manufacturing operations especially with regard to equipment issues.
- Raise and lead GMP change requests for implementation of changes to equipment and facilities.
- Support all phases of engineering project implementation to meet scope, schedule, budget, quality, and safety requirements.
- Responsibility to adhere to any applicable EHS requirements.
- Any other duties as assigned by supervisor.
Education and Experience Requirements
- Degree in Biotechnology/Mechanical/Chemical engineering/ or equivalent .
- Experience in an engineering role supporting cGMP operations in a pharmaceutical/ biopharmaceutical manufacturing plant is required.
- Demonstrated mastery of technical drawings, general arrangement drawings, and equipment design drawings is required.
- Experience in the design and operation of biopharmaceutical manufacturing equipment and facilities.
- Experience in the management and coordination of engineering and construction management consultants, equipment vendors and contractors.
Key Skills and Competencies
- Excellent Communication Skills
- Project Management Skills
- Technical Knowledge
- Judging/Problem Solving
- Quality/Attention to Details
- Teamwork/Collaboration
