Pharmaceutical Process Engineer (Office Hours 5 Days, Biomedical)
Recruit Express Pte Ltd.
Singapore
SGD 60,000 - 80,000
Job description
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 and modified equipment.
Perform Software FAT using PCS7.
Responsibilities
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.
Coordinate with multi-disciplinary teams such as 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.
Adhere to applicable EHS requirements.
Maintain a fair and respectful relationship with others and behave in accordance with the Code of Conduct.
Perform any other duties as assigned by the process engineering team.
Education and Experience Requirements
Minimum Degree in Chemical/Bio/Process/Mechanical engineering discipline and a minimum of 2 years of experience in Biologics, Pharmaceuticals, and/or similar manufacturing industries.
Minimum Diploma in Chemical Engineering/Biologics & Process Technology/Chemical & Pharmaceutical Technology/Biotechnology/Chemical & Biomolecular Engineering or related, with 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
Good understanding of design principles and standards within biopharmaceutical facilities.
Process and equipment knowledge of biological drug substance manufacturing processes; upstream/downstream unit operations expertise is highly preferable.
Ability to read and understand PCS7 Functional Specifications; 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.
Strong project management skills.
Understanding of equipment commissioning, various stages of qualification, and process activities.
If you are interested in the position, please send your most updated resume to leonleong@recruitexpress.com.sg (Attn: Process Engineer).