Pharmaceutical Process Engineer (Office Hours 5 Days, Biomedical)
Primary Objectives of this Job Demonstrate ability to lead technical projects from concept through implementation together with Process Engineering team. Assist with execution of qualification protocols for IQ, OQ Perform activities like IGI (incoming goods inspection), FAT/SAT and Installation verification for new equipment’s and also for existing modified equipment’s. Perform Software FAT using PCS7. Responsibilities Review vendor turnover package documentation Manage equipment construction activities associated with implementation of engineering projects Support all phases of engineering project implementation to meet scope, schedule, budget, quality, and safety requirements Coordinates with multi-disciplinary team like Automation, Manufacturing, PDTS and Validation for improvements or implementing changes associated with engineering projects. Draft and execute commissioning protocols related to production equipment in the Cell Culture or Purification areas. Responsibility to adhere to any applicable EHS requirements. Commitment to a fair and respectful relationship to others and behavior in accordance with Code of Conduct. Any other duties as assigned by process engineering team Education and Experience Requirements Min Degree in Chemical/Bio/Process/Mechanical engineering discipline and Minimum 2 years of experience in Biologics, Pharmaceuticals and/or similar manufacturing industries, Min Diploma in Chemical Engineering / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Biotechnology / Chemical & Biomolecular Engineering or related and possess more than 3 years of relevant experience in the biotechnology or pharmaceutical industry Experience in bio-processing engineering in a manufacturing environment is highly desirable Experience in a GMP environment is preferred Key Skills and Competencies A good understanding of design principles and standards within the biopharmaceutical facilities Process and equipment knowledge of biological drug substance manufacturing processes; upstream /downstream unit operations expertise highly preferable Good communication skills Read &Understand PCS7 Functional Specification and Knowledge/ Experience in Siemens PCS7 is preferable. Knowledge/ Experience in DeltaV, is an added advantage Thorough knowledge of current Good Manufacturing Practices (cGMP) and Good Engineering Practices (GEP) Good knowledge of EHS and risk management practices Good Project Management Skill Understanding equipment commissioning, various stages of qualification and process activities Thank You. Leon Leong De Cong R1551708 EA License: 99C4599