Job Description

Responsibilities

: " Department: Process Engineering Position of Reporting Supervisor: Process Engineering Manager Primary Objectives of this Job Experience in Downstream bioprocess operations and Demonstrated experience in equipment design such as chromatography skids, Ultrafiltration&Diafiltration skid, Filtration skids, Tank farms, Autoclave, Parts washer and CIP systems, Active participation in Basic &Detail design, Commissioning and Qualification phase of the project. Demonstrate ability to support the project from concept through implementation together with Takeda Process Engineering team and EPCM Contractors Responsibilities Work with Design and Construction Management firms (EPCM), together with Takeda 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. Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda Code of Conduct. Any other duties as assigned by Takeda process engineering team. 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 equipments. Ability to effectively communicate via writing and oral communication at all levels. ", "identifier":{ "@type": "PropertyValue", "name":"Kingfisher Recruitment (singapore) Pte. Ltd.", "value": "*******" }, "datePosted": "2022-08-03", "validThrough": "2022-09-02", "url": "********************", "employmentType" : "FULL_TIME",
Benefits