Job Description :
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.
Education and Experience Requirements
- 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
Key Skills and Competencies
- 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
- 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
If you are interested in the position, do kindly drop your most updated resume to [HIDDEN TEXT] (Attn: Process Engineer - Leon)
Leon Leong De Cong
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599