Process Engineer

Syngene International

Bangalore, Karnataka
Permanent
Full-time

18 days ago

JOB DESCRIPTIONDesignation: Deputy ManagerLevel: 7 - IIJob Location: BangaloreThe CompanySyngene 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

Equal Opportunity EmployerIt is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.Pls visit us at to know more about us and what we do.

Syngene International

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