3 Years Contract Process Engineer - BIOPHARMA MANUFACTURING PLANT
- Work with Design and Construction Management firms (EPCM), together with process engineers to support and complete following tasks within schedule;
- Involve in Basic and Detail design phase of project.
- Review P&IDs, standard detail drawings, URS, HAZOP study report etc.,
- Review 3D model and 2D layouts as appropriate, general arrangement and isometric drawings for construction & installation
- Review detailed specification datasheets for equipment, valves, instruments, piping etc.,
- Review testing and commissioning procedures
- Involve Factory Acceptance Testing (FAT) of all process equipment’s.
- Involve Inspection Site installation of new equipment’s upon delivery.
- Review of Vendor Turnover Packages and Construction Trade Turnover Packages.
- Involve in Design Qualification.
- Review Functional specifications
- Participate in Software FAT using PCS7.
- Involve Commissioning and Qualification of new equipment’s in the Downstream (Purification) areas. Which include reviewing of C&Q documents
- Review Punch list and follow-up until successful handover.
- Review hand-over records
- Coordinates with multi-disciplinary team like Automation, Manufacturing, PDTS and Validation for improvements or implementing changes associated with projects.
- Responsibility to adhere to any applicable EHS requirements.
Education and Experience Requirements
- 3 to 5+ years of experience in Downstream bioprocess operations and Demonstrated experience in equipment design in Pharmaceutical/biopharmaceutical industry
- Experience in an engineering role supporting cGMP operations in a Pharmaceutical/biopharmaceutical manufacturing plant is highly desirable.
- 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
- Process and equipment knowledge of biological drug substance manufacturing processes; downstream unit operations expertise highly preferable
- Read &Understand PCS7 Functional Specification and Knowledge/ Experience in Siemens PCS7 is preferable.
- Knowledge/ Experience in DeltaV, is an added advantage
- Understanding equipment commissioning, various stages of qualification and process activities.
- Thorough knowledge of current Good Manufacturing Practices (cGMP) and Good Engineering Practices (GEP)
- A good understanding of design principles and standards within the biopharmaceutical facilities.
- Strong knowledge of sanitary design aspects of biopharmaceutical manufacturing equipment’s.
- Ability to effectively communicate via writing and oral communication at all levels.
Interested candidates please submit your resume to [Click Here to Email Your Resume]
Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)
Recruit Express Pte Ltd