Process Engineer
2 months ago
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
Tell employers what skills you have
Troubleshooting
CAPA
Construction
Hardware
cGMP Practices
GMP
Investigation
FDA GMP
Root Cause Analysis
Process Engineering
Piping
Unit Operations
Engineering Design
Audits
Instrumentation
Pharmaceuticals
Manufacturing
Commissioning
EHS
Technical Support
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