Technologist

• Set up, maintain a variety of automated and manually operated equipment and perform production activities in downstream processes: clarification by centrifugation and TFF, purification by zonal centrifugation, splitting by continuous flow centrifugation, inactivation, diafiltration and sterile filtration of drug substance.
• Perform troubleshooting and assessment of processes and technical problems.
• Clean-in-place (CIP), cleaning-out-of-place (COP) of downstream equipment and vessels.
• Provide training to personnel.
• Execute and verify IQ/OQ/PQ validation and cleaning verification protocols.
• Perform other duties as assigned by department management throughout all stages of drug substance manufacturing related to B200 operations (MWS, Upstream and Downstream processes).
• Ensure all equipment, instruments and systems are properly assembled, installed, tested and maintained.
• Participate in preventive maintenance of production equipment and instruments.

• Sample processed materials and perform in-process testing according to procedures.
• Deliver samples to other departments on site as required.
• Perform area-specific testing, utility sampling and environmental monitoring for production.

• Perform routine cleaning and disinfection activities in classified environments.
• Maintain and organize cleanroom in good cGMP state and ensure area is always inspection ready.
• Submit equipment/material orders and maintain inventory of spare parts, purchased materials for downstream processing.
• Maintain safe and clean work environment by following site procedures and cGMP regulations.
• Participate in facility preparation and inspection readiness, safety and process audits.

• Document, review and maintain production and monitoring activities for Influenza drug substance manufacturing
• Draft, review and revise cGMP documents (SOPs/SWis, batch records, protocols, change controls, reports and other manufacturing supporting documents).
• Analyze, enter & verify data on paper based or electronic documents.
• Follow all SWI/SOPs and comply to site policies and procedures.

1. Participate in continuous process and equipment improvement, Health, Safety & Environment, Quality, and Inspection readiness initiatives

• Perform and participate in continuous improvement and development projects.
• Initiate Deviations, CCR, CAPA in Quality system as needed and assist until completion as per committed due dates
• Participate in deviation investigations and root cause analysis.
• Follow HSE SOPs, identify and minimize risks, promote safety culture.
• Comply with HSE guidelines on the disposal of waste.

No employee has a proprietary right to an activity or group of activities. Activities may be changed or reassigned to meet the needs of the operations.

:

• Minimum (3) three years College's diploma degree (Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences), plus a minimum of (1) one year of previous relevant work experience.

Skills and Knowledge:

• Purification Process for viral proteins
• Production Equipment
• Aseptic Technique
• Current Good Manufacturing Practices (cGMPs)
• Chemistry, Microbiology, Biochemistry, Mathematics, Computer
• Mechanical Aptitude

Hours Of Work:

• Inclusive from Sunday to Thursday/ Tuesday to Saturday/ Friday to Tuesday 10:00 PM - 6:00 AM.

​ ​This is subject to change at any time and it should not be construed as limiting the right of the company to make such a change to meet the requirements of the operation.

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness program

This position is for a new vacant role that is now open for applications.​