Senior / MSAT Engineer
Roche Singapore Technical Operations Pte Ltd
jobsDB ref: JSG400003003187959
- Support manufacturing operations (downstream processing)
- Required to work effectively as part of a team responsible for ensuring successful and efficient production processes for clinical and marketed recombinant proteins
- Provide ongoing technical and scientific support for the unit operations utilized in the manufacture of these proteins
- Monitor, optimize, validate, and troubleshoot issues related to either fermentation/cell culture or protein purification processes
- Perform product impact and root cause assessments for process discrepancies and quality investigations
- Identify and implement corrective actions and other process and equipment improvements
- Develop, monitor, optimize and troubleshoot cleaning processes
- Support the technology transfer of new processes/products to Roche Singapore Technical Operations
- Create, review and revise technical reports, validation protocols/ reports and engineering documents such as URS, FS, SDS, etc.
- Create, review and revise cGMP documents such as production batch records, SOPs, etc.
- Create change records
- Develop training material and conduct training for production and technical staff
- Create, review and revise risk assessments and hazards analyses
- Support regulatory inspections and filings
- Perform lab-scale experiments in support of process monitoring, improvements, and validation
- BA/BS or higher in a scientific or engineering discipline
- Knowledge of safety principles, quality systems, and cGMP
- Relevant work experience in a lab, pilot plant, or large-scale protein production processes and equipment
- Ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.
- Must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills.
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About Roche Singapore Technical Operations Pte Ltd
Roche Singapore Technical Operations is Roche’s first biologics manufacturing site within Asia region, and the first company in Singapore to produce US FDA licensed bio therapeutics using recombinant DNA technologies.
Our Vision and Mission
We will be the most admired biotechnology production operation, respected for our world class innovation, engrained quality inspired people and operational excellence.
Quality is every patient’s right and every employee’s responsibility. Quality provides a competitive advantage and is engrained in everything we do, from concept through continuous improvement. Because Roche’s products touch human lives, quality is the true measure of our success.
The Business of Improving Human Lives
With over 500 employees, two state-of-the-art facilities, using two different production technology platforms to manufacture bacterial and mammalian cell-based products – all within a 12.6 hectare biomedical space. Here is where we produce the biologic medicines that target a wide spectrum of patients and conditions. Our facilities are designed for multi-product drug substance manufacturing based on CHO and E.Coli platforms. The 26,000 m² CHO facility manufactures Avastin, an anti-angiogenesis therapy for colorectal, lung, kidney, breast and brain cancer patients; and Herceptin, a therapeutic antibody for metastatic breast cancer. The 3,084 m2 E.Coli facility, on the other hand, yields Lucentis, a treatment for patients with wet age-related macular degeneration, a leading cause of blindness in people over 55. The entire operation is supported by external infrastructure which includes a power substation, waste neutralization, industrial gases and water storage.
Why Join Us?
Be part of a business where human lives are the true beneficiaries. Roche is a world leader in research-focused healthcare with dual pillars of strength in pharmaceuticals and diagnostics. As frontrunners in biologics manufacturing, we are firmly grounded through our longstanding expertise in biopharmaceutical manufacturing and our production capacity.
At Roche, our focus is on the development of medicines and diagnostics that will extend and improve the lives of patients. Roche strives to discover, develop and provide innovative diagnostic and therapeutic products and services that deliver significant benefits to patients and healthcare professionals that will improve the lives of patients everywhere.
At Roche, we do this in a responsible and ethical manner through our commitment to sustainable development while respecting the needs of people, society and the environment. Roche employees cite the chance to make a difference in the lives of patients as the number one reason they enjoy working at the company. In hiring new employees, Roche looks for people who are inspired by this mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because Roche knows that employees are critical to its success in bringing novel medicines to patients, the company is dedicated to remaining a great place to work and to providing employees with programmes, services and benefits that allow them to bring the best to the business and their personal lives.