Designation: Deputy Manager
Level: 7 - II
Job Location: Bangalore
The Company
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.
Position Summary:
We are seeking a highly motivated and skilled
Process Engineer
with a strong background in biopharmaceutical manufacturing
or process design
, preferably with expertise in upstream operations
. This role focuses on
upstream unit operations
including bioreactor design and operation
, centrifugation
with an added advantage for candidates who bring cross-functional exposure to downstream purification processes
as well.
Functional Responsibilities:
- Lead or support process design, continuous improvement, and optimization of upstream unit operations (e.g., seed train, production bioreactors, harvest systems)
- Develop, review, and approve process documentation including P&IDs, process descriptions, interface to Automation
- Work collaboratively with cross-functional teams in MSAT, Quality, Engineering and Operations to ensure seamless tech transfer and process implementation
- Troubleshoot process-related issues during manufacturing campaigns and provide real-time support
- Participate in capital projects involving design or retrofit of biopharmaceutical facilities, including equipment selection, specification, and commissioning/qualification
- Evaluate and implement process improvements for robustness, yield, and productivity enhancements
- Maintain awareness of new technologies and trends in upstream and downstream processing
Primary Responsibilities:
- Project Ownership: Accountable for the successful execution of projects from initiation through completion, ensuring all deliverables meet client expectations and regulatory standards.
- Quality Assurance: Responsible for ensuring that all processes comply with cGMP and other regulatory requirements, thereby safeguarding product quality and patient safety.
- Client Satisfaction: Ensure high levels of client satisfaction through effective communication, timely updates, and proactive problem-solving.
- Compliance and Risk Management: Identify and mitigate risks associated with technology transfer, ensuring that all operations are compliant with internal and external guidelines.
- Develop and validate process maps and models in collaboration with cross-functional teams.
- Adapt to additional tasks and responsibilities as assigned, demonstrating flexibility and a proactive approach.
Education
- Bachelor s, Master s in Biotechnology, Chemical Engineering, Mechanical Engineering, Industrial Process Engineering, or a related discipline
- 5 8 years of relevant experience in biopharmaceutical manufacturing or engineering-equipment design, preferably in a GMP-compliant environment
- In-depth knowledge of upstream operations such as bioreactor operation (mammalian, microbial) and centrifugation from instrumentation and P&ID to DCS level
- Exposure to solution preparation, downstream processing (chromatography, UF/DF, nanofiltration) is a plus
- Familiarity with process control systems (DeltaV, PLC/SCADA) and PAT tools is advantageous
- Familiarity to ASPEN, Auto CAD, 3D design along with CMMS tools for asset management
- Strong understanding of ASME BPE, cGMP, ICH, and regulatory expectations for biopharma manufacturing
- Excellent analytical, problem-solving, and communication skills
Preferred Attributes:
- Experience with single-use technologies (SUT) and Stainless-Steel technologies in bioprocessing
- Prior involvement in facility design or greenfield/brownfield projects
- Hands-on experience in process modelling or simulation tools (e.g., Aspen Plus, SuperPro, schedule pro Designer or similar)
- Lean Six Sigma or similar process improvement methodology certification is a plus but not a must
