Process Engineer
Process Engineer
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Job Description
JOB DESCRIPTION
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. Syngenes 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 operationsincluding bioreactor design and operation centrifugationwith 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
- Bachelors Masters in Biotechnology Chemical Engineering Mechanical Engineering Industrial Process Engineering or a related discipline
- 58 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 Employer
It 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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.
Pls visit us athttps:// to know more about us and what we do.
Employment Type
Full Time
