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. Drawings may include PFDs, P&IDs as well as others. 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 (such as vessel data sheets, etc.).
- 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).
- Support the development of URS’s, Risk Assessments, Commissioning and Validation strategies,
- Commissioning project Plan, Validation Project Plan, Design Qualifications, Traceability Matrices,
- 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 including IQ, OQ, and PQ.
- Author standard operating procedures (SOPs) for process equipment maintenance and preventive maintenance (PM) checklists.
- Execution of activities like IGI, hardware FAT/SAT & installation verification associated with equipment changes and new equipment installations.
- 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.
- Timely closure of EHS and Quality event investigation and Corrective Actions / Preventative Actions (CAPA) tasks.
- 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.
- You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities).
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 including PFDs, P&IDs, 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.
- Detailed knowledge of ASME Bioprocessing Equipment (BPE) guidelines.
Key Skills and Competencies
Excellent Communication Skills
- Ability to effectively communicate via writing and oral communication at all levels.
- Express ideas effectively in individual and group situations (including non-verbal communication).
- Ability to communicate to internal and external personnel and to communicate technical information to both technical and non-technical people.
Project Management Skills
- Ability to handle project, keeping track of costs and schedule and ensuring compliance with quality and safety standards.
- Use organizational skills to prioritize and resolve project issues.
Technical Knowledge
- Proficiency with troubleshooting of complex equipment and performing formal root cause analysis investigations.
- Demonstrated ability to lead technical projects from concept through implementation.
- A good understanding of design principles and standards within the biopharmaceutical facilities.
- Strong knowledge of sanitary design aspects of biopharmaceutical manufacturing equipment including Clean in Place (CIP) and Steam in Place (SIP) concepts
- Knowledge of unit operations associated with cell culture and downstream processing including: media and buffer preparation, bioreactors, depth filtration, sterile filtration, single-use technologies and chromatography skids & columns.
- Ability to look at plant problems and come up with options for solutions.
- Ability to understand and challenge design and execution concepts from outside vendors/engineers.
Judging/Problem Solving
- Ability to develop alternative courses of action that are based on logical assumptions, factual data and engineering principles.
- The alternate actions take into consideration resources (financial and manpower), constraints and organizational priorities.
- Provides solutions to a wide range of difficult problems; solutions are imaginative, thorough and practicable.
- Gain approval for recommended solution and implement through proper channels.
Quality/Attention to Details
- Ability to accomplish tasks through concern for all areas involved.
- Demonstrating the proper level of detail for all aspects of the job; accurately checking processes, data and tasks; and maintaining attention over a period of time.
Teamwork/Collaboration
- Ability to work effectively with internal and external teams or those outside formal line of authority (e.g. peers, senior managers) to accomplish goals.
- Take actions that respect the needs and contributions of others; contributing to and accepting the consensus; subordinating own objectives to the objectives of the project team.
- Represents the organization in providing solutions to difficult technical problems; frequent interorganizational and global contacts.
- An understanding of how to work through company systems to establish goals.
Initiative
- Ability to make active attempts to influence events to meet the goals of the project or organization.
- Given very general direction, independently determines and develops an approach to problem solving or project execution.
- Reviews work in terms of meeting project and organizational objectives.
